Legal provisions of COM(2022)462 - Amending numerous Directives on emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

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dossier COM(2022)462 - Amending numerous Directives on emergency procedures for the conformity assessment, adoption of common specifications and ...
document COM(2022)462 EN
date September 19, 2022

Contents

Article 1 - Amendments to Directive 2000/14/EC

Directive 2000/14/EC is amended as follows:

the following articles are inserted:

‘Article 17a
Application of emergency procedures

1. Member States shall ensure that measures taken to transpose Articles 17b, 17c and 17d of this Directive only apply if Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 226 of [the SMEI Regulation] with respect to this Directive.  

2. Member States shall ensure that measures taken to transpose in Articles 17b, 17 c and 17d apply exclusively to equipment, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose in Articles 17b, 17c and 17d apply during the Single Market emergency mode.

However, Article 17c(2), second subparagraph, and Article 17c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to equipment placed on the market in accordance with Article 17c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19a(2).

Article 17 - b Prioritisation of the conformity assessment of crisis-relevant equipment

1. This Article shall apply to equipment listed in the implementing act referred to in Article 17a(1), which is subject to conformity assessment procedures in accordance with Article 14, which require the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of equipment designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of equipment designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of equipment, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of equipment designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 17a.

4. The prioritisation of applications for conformity assessment of equipment pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for equipment designated as crisis-relevant goods in respect of which they have been notified.

Article 17 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 14, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of specific equipment referred to in Article 12 and listed in the implementing act referred to in Article 17a(1)and for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in Article 14 have not been carried out by a notified body but for which the compliance with all the applicable requirements concerning the noise emission in the environment of this Directive has been demonstrated.

2. The manufacturer of equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the equipment concerned complies with all the applicable requirements concerning the noise emission in the environment of this Directive and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the equipment, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the equipment may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable requirements concerning the noise emission in the environment of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the equipment concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the equipment concerned;

(e)measures to be taken with respect to the equipment concerned upon expiry of the authorisation in order to ensure that the equipment concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 17a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation fromArticles 6 and 11, equipment, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not benefit from free movement across the Union and shall not bear the CE marking. The market surveillance authorities are not required to recognise the validity of authorisations issued by the competent national authorities of another Member State.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such equipment.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of equipment in accordance with paragraph 1.

8. The application of Articles 17a to 17d and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 14 on the territory of the Member State concerned.

Article 17 - d Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for equipment, designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for equipment, designated as crisis-relevant goods.’

(2) Article 18, is amended as follows:

(a)In paragraph 1, the following sentence is added after the first sentence: ‘That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.’ ‘The committee referred to in Article 18 shall:’;; ‘The committee referred to in Article 18 shall:’;

(b)the following paragraph is added after paragraph 1:

‘2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.’

Article 2 - Amendments to Directive 2006/42/EC

In Directive 2006/42/EC, the following articles are inserted:

‘Article 21b
Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 21c to 21h of this directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 21c to 21h are apply exclusively to machinery, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 21c to 21h apply during the Single Market emergency mode.

However, Article 21d(2), second subparagraph, and Article 21d(5) shall apply during the Single Market emergency mode and after its deactivation or expiry. 


4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to machinery placed on the market in accordance with Articles 21d to 21g. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(3).

Article 21 - c Prioritisation of the conformity assessment of crisis-relevant machinery

1. This Article shall apply to machinery designated as crisis-relevant goods, which is subject to conformity assessment procedures in accordance with Article 12, which require the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of machinery designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of machinery designated as crisis-relevant goodsshall be processed as a matter of priority, ahead of any other applications for conformity assessment of machinery, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of machinery designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 21b.

4. The prioritisation of applications for conformity assessment of machinery pursuant to paragraph 2 and 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for machinery designated as crisis-relevant goods in respect of which they have been notified.

Article 21 - d Derogation from party conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 12, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of specific machinery which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in Article 12 have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated.

2. The manufacturer of machinery subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the machinery concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the machinery, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the machinery concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the machinery concerned;

(e)measures to be taken with respect to the machinery concerned upon expiry of the authorisation in order to ensure that the machinery concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 21d(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3, also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 6 and 16, machinery, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive 57  with respect to such machinery.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of machinery in accordance with paragraph 1.

8. The application of Articles 21b to 21h and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 12 on the territory of the Member State concerned.

Article 21 - e Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into service, their competent authorities consider that the machinery which complies with of relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential health and safety requirements set out in Annex I, complies with those essential health and safety requirements in either of the following cases:

a) where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

b) where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012

Article 21 - f Adoption of common specifications conferring a presumption of conformity

1. Where machinery has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such machinery to cover the essential health and safety requirements set out in Annex I, in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where the severe disruptions in the functioning of the Single Market which led to the activation the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation]significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 22(3).They shall apply to machinery placed on the market until the last day of the period for which the Single Market emergency mode has been activated in accordance with Article 15(4) of [the SMEI Regulation]. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 7, machinery which is in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential health and safety requirements set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 21b(3), first subparagraph, unless there is sufficient reason to believe that the machinery covered by the common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the machinery in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential health and safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 21 - g Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential health and safety requirements set out in Annex I for machinery listed in the implementing act referred to in Article 21b(1).

2. The implementing acts establishing mandatory common specifications referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the procedure referred to in Article 22(3). They shall apply to machinery placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 21b(3), first subparagraph, unless there is sufficient reason to believe that the machinery covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the machinery in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 21 - h Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for machinery, designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for machinery designated as crisis-relevant goods.’

Article 3 - Amendments to Directive 2010/35/EU

Directive 2010/35/EU is amended as follows:

the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 33 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d apply exclusively to transportable pressure equipment, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d apply during Single Market emergency mode.

4. However, Article 33c(2), second subparagraph, and Article 33c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.


5. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to transportable pressure equipment placed on the market in accordance with Article 33c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38a(2).

Article 33 - b Prioritisation of the conformity assessment of crisis-relevant transportable pressure equipment

1. This Article shall apply to transportable pressure equipment designated as crisis-relevant goods, which is subject to conformity assessment procedures in accordance with Article 12, which require the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of transportable pressure equipment designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of equipment designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of equipment, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of transportable pressure equipment designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 33a.

4. The prioritisation of applications for conformity assessment of transportable pressure equipment pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for transportable pressure equipment designated as crisis-relevant goods in respect of which they have been notified.

Article 33 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 12, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific transportable pressure equipment designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 12 have not been carried out by a notified body but for which the compliance with all the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive has been demonstrated.

2. The manufacturer, the importer,the distributor and the user of a transportable pressure equipment subject to the authorisation procedure referred to in paragraph 1 of this Article shall declare on his sole responsibility that the transportable pressure equipment concerned complies with all the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer, the importer, the distributor and the user shall also deploy all reasonable measures to ensure that the transportable pressure equipment, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issues by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the transportable pressure equipment may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the transportable pressure equipment concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the transportable pressure equipment concerned;

(e)measures to be taken with respect to the transportable pressure equipment concerned upon expiry of the authorisation in order to ensure that the transportable pressure equipment concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 33a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 14 and 16, transportable pressure equipment, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State that has granted the authorisation .

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such transportable pressure equipment.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of a transportable pressure equipment in accordance with paragraph 1.

8. The application of Articles 33a to 33d and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 12 on the territory of the Member State concerned.

Article 33 - d Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for transportable pressure equipment, designated as crisis-relevant goods.

The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for transportable pressure equipment, designated as crisis-relevant goods.

2. the following Article is inserted:

Article 38 - a Committee procedure

1. The Commission shall be assisted by the committee on the transport of dangerous goods established by Article 9 of Directive 2008/68/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 4 - Amendments to Directive 2013/29/EU

In Directive 2013/29/EU, the following Chapter 5a is inserted:

‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 42 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 42b to 42g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 42b to 42g apply exclusively to pyrotechnic articles, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 42b to 42g apply during the Single Market emergency mode.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to pyrotechnic articles placed on the market in accordance with Articles 42c to 42f. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

Article 42 - b Prioritisation of the conformity assessment of crisis-relevant pyrotechnic articles

1. This Article shall apply to all pyrotechnic articles designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 17 requiring the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of pyrotechnic articles designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of equipment designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of equipment, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of pyrotechnic articles designated as crisis-relevant goods, irrespective of, whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 42a.

4. The prioritisation of applications for conformity assessment of pyrotechnic articles pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for pyrotechnic articles designated as crisis-relevant goods in respect of which they have been notified.

1. Article 42c
Derogation from party conformity assessment procedures requiring mandatory involvement of a notified body By way of derogation from Article 17, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific pyrotechnic article which has been designated as crisis-relevant good and for which the conformity assessment procedures which require the mandatory involvement of a notified body referred to in Article 17 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

2. The manufacturer of a pyrotechnic article subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the pyrotechnic article concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

3. The manufacturer shall also deploy all reasonable measures to ensure that the pyrotechnic article, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

4. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the pyrotechnic article may be placed on the market, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential safety requirements of Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the pyrotechnic article concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the pyrotechnic article concerned;

(e)measures to be taken with respect to the pyrotechnic article concerned upon expiry of the authorisation in order to ensure that the pyrotechnic article concerned is brought back in compliance with all the requirements of this Directive.

5. By way of derogation from Article 42a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

6. By way of derogation from Articles 4 and 20, pyrotechnic articles, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not benefit from free movement across the Union and shall not bear the CE marking. The market surveillance authorities are not required to recognise the validity of authorisations issued by the competent national authorities of another Member State.

7. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such pyrotechnic articles.

8. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of a pyrotechnic article in accordance with paragraph 1.

9. The application of Articles 42a to 42g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 17 on the territory of the Member State concerned.

Article 42 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider that pyrotechnic articles which comply with the relevant international standards or any national standards in force in the Member State of manufacture, if such standards ensuring the safety level required by the essential safety requirements set out in Annex I, complies with those essential safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 42 - e Adoption of common specifications conferring a presumption of conformity

1. Where pyrotechnic articles, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts for such pyrotechnic articles establishing common specifications to cover the essential safety requirements set out in Annex I in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3). They shall apply to for pyrotechnic articles placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 16, pyrotechnic articles which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential safety requirements set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 42a(3), first subparagraph, unless there is sufficient reason to believe that the pyrotechnic articles covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the pyrotechnic articles in compliance with the said common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation]. 

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 42 - f Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential safety requirements set out in Annex I for pyrotechnic articles, which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3) and they apply to pyrotechnic articles placed on the market until the last day of the period for which the Single Market emergency remains active. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 42a(3), first subparagraph, unless there is sufficient reason to believe that the pyrotechnic articles covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the pyrotechnic articles in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 42 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for pyrotechnic articles designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for pyrotechnic articles designated as crisis-relevant goods.’

Article 5 - Amendments to Directive 2014/28/EU

In Directive 2014/28/EU, the following Chapter 6a is inserted:

‘CHAPTER 6a
EMERGENCY PROCEDURES

Article 45 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 45b to 45g of this Directive shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 45b to 45g apply exclusively to explosives, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 45b to 45g apply during the Single Market emergency mode. 

However, Article 45c(2), second subparagraph, and Article 45c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to explosives placed on the market in accordance with Articles 45c to 45f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 49(3).

Article 45 - b Prioritisation of the conformity assessment of crisis-relevant explosives

1. This Article shall apply to explosives designated as crisis-relevant goods, which are subject to conformity assessment procedures, in accordance with Article 20requiring the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of explosives designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such explosives designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for equipment, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of explosives designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 45a.

4. The prioritisation of applications for conformity assessment of explosives pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, which have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for explosives designated as crisis-relevant goods in respect of which they have been notified.

Article 45 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 20, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific explosive which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in that Article 20 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

2. The manufacturer of an explosive subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the explosive concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the explosive, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the explosive may be placed on the market, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the explosive concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the explosive concerned;

(e)measures to be taken with respect to the explosive concerned upon expiry of the authorisation in order to ensure that the explosive concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 45a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 3 and 23, explosives, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such explosives.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of an explosive in accordance with paragraph 1.

8. The application of Articles 45a to 45g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 20 on the territory of the Member State concerned.

Article 45 - d Presumption of conformity based on national and international standards

(a)Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities conside rthat the explosives which comply with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential safety requirements set out in Annex II, complies with those essential safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex II to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 45 - e Adoption of common specifications conferring a presumption of conformity

1. Where explosives, has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts for such explosives establishing common specifications to cover the essential safety requirements set out in Annex II in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex II already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 49(3).  They shall apply to the explosives placed on the market until the last day of the period for which the Single Market emergency mode remains applicable in accordance with [the SMEI Regulation]. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 19, explosives which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential safety requirements set out in Annex II covered by those common specifications or parts thereof.

4. By way of derogation from Article 45a(3), first subparagraph, unless there is sufficient reason to believe that the explosives covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the explosives in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety requirements which it aims to cover and which are set out in Annex II, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 45 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential safety requirements set out in Annex II for explosives which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 49(3) and they shall apply to explosives placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 45a(3), first subparagraph, unless there is sufficient reason to believe that the explosives covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the explosives in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 45 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for explosives designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for explosives, designated as crisis-relevant goods.’

Article 6 - Amendments to Directive 2014/29/EU

In Directive 2014/29/EU, the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 38 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 38b to 38g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply exclusively to vessels, which have been designated as crisis-relevant goods in the Commission implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply during the Single Market emergency mode.

However, Article 38c(2), second subparagraph, and Article 38c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to vessels placed on the market in accordance with Articles 38c to 38f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 39(3).

Article 38 - b Prioritisation of the conformity assessment of crisis-relevant vessels

1. This Article shall apply to vessels designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 13 requiring the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of vessels designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of vessels designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of equipment, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of vessels designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 38a.

4. The prioritisation of applications for conformity assessment of vessels pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for vessels designated as crisis-relevant goods in respect of which they have been notified.

Article 38 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 13, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific vessel which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 13 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

2. The manufacturer of a vessel subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the vessel concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the vessel, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the vessel may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the vessel concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the vessel concerned;

(e)measures to be taken with respect to the vessel concerned upon expiry of the authorisation in order to ensure that the vessel concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 38a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 5 and 16, vessels, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking and inscriptions.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such vessels.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a vessel in accordance with paragraph 1.

8. The application of Articles 38a to 38g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 13 on the territory of the Member State concerned..

Article 38 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into service, their competent consider vessels which comply with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring a safety level required by the essential safety requirements set out in Annex I, complies with those essential safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 38 - e Adoption of common specifications conferring a presumption of conformity

1. Where vessels, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts for such vessels establishing common specifications to cover the essential safety requirements set out in Annex I, in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)the severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 39(3). They shall apply to vessels placed on the market until the last day of the period for which the Single Market emergency mode remains active in accordance with Article 15(4) of [the SMEI Regulation]. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 12, vessels which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential safety requirements set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 38a(3), first subparagraph, unless there is sufficient reason to believe that the vessels covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the vessels in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 38 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential safety requirements set out in Annex I for vessels, which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 39(3) and they shall apply to vessels placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 38a(3), first subparagraph, unless there is sufficient reason to believe that the vessels covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the vessels in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 38 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for vessels, designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for vessels, designated as crisis-relevant goods.’

Article 7 - Amendments to Directive 2014/30/EU

Directive 2014/30/EU is amended as follows:

the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 40 - a Application of mergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 40b to 40g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 40b to 40g apply exclusively to apparatus, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 40b to 40g apply during the Single Market emergency mode.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to apparatus placed on the market in accordance with Articles 40c to 40f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(2a).

Article 40 - b Prioritisation of the conformity assessment of crisis-relevant apparatus

1. This Article shall apply to apparatus designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 14 requiring the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of apparatus designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of apparatus designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for equipment, which has not been designated as crisis-relevant goods. This requirement is applies with respect to all applications for conformity assessment of apparatus designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 40a.

4. The prioritisation of applications for conformity assessment of apparatus pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for apparatus designated as crisis-relevant goods in respect to which they have been notified.

Article 40 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 14, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific apparatus which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 14have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

2. The manufacturer of apparatus subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the apparatus concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the apparatus, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation .

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the apparatus may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the apparatus concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the apparatus concerned;

(e)measures to be taken with respect to the apparatus concerned upon expiry of the authorisation in order to ensure that the apparatus concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 40a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 5 and 17, apparatus, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such apparatus.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of apparatus in accordance with paragraph 1.

8. The application of Articles 40a to 40g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 14 on the territory of the Member State concerned.

Article 40 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into service, their competent authorities consider that apparatus which complies with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring a safety level required by the essential health and safety requirements set out in Annex I , complies with those essential health and safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 or

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 40 - e Adoption of common specifications conferring a presumption of conformity

1. Where apparatus, has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts for such apparatus establishing common specifications to cover the essential health and safety requirements set out in Annex I, in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 41(2a). They shall apply to apparatus placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 13, apparatus which is in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 40a(3), first subparagraph, unless there is sufficient reason to believe that the apparatus covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the apparatus in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 40 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential health and safety requirements set out in Annex I for apparatus, which has been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 41(2a). They shall apply to apparatus placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 40a(3), first subparagraph, unless there is sufficient reason to believe that the apparatus covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the apparatus in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 40 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for apparatus, designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for apparatus, designated as crisis-relevant goods.’

3. in Article 41, the following paragraph 2a is inserted:

2a. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 8 - Amendments to Directive 2014/31/EU

In Directive 2014/31/EU, the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 40 - a Application of emergency procedures, and their deactivation

1. Member States shall ensure that measures taken to transpose Articles 40b to 40g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 40b to 40g apply exclusively to instruments, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 40b to 40g apply during the Single Market emergency mode.

However, Article 40c(2), second subparagraph, and Article 40c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to instruments placed on the market in accordance with Articles 40c to 40f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(3).

Article 40 - b Prioritisation of the conformity assessment of crisis-relevant instruments

1. This Article shall apply to instruments designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 13 requiring the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of instruments designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such instruments designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of instruments, which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of instruments designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 40a.

4. The prioritisation of applications for conformity assessment of instruments pursuant to paragraph 2 and 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for instruments designated as crisis-relevant goods in respect to which they have been notified.

Article 40 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 13, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific instrument which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 13have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

2. The manufacturer of an instrument subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the instrument concerned complies with all the applicable essential requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the instrument, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the instrument may be placed on the market, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the instrument concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the instrument concerned;

(e)measures to be taken with respect to the instrument concerned upon expiry of the authorisation in order to ensure that the instrument concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 40a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 5 and 16, instruments, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisationand shall not bear the CE marking, nor the supplementary metrology marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such instruments.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of an instrument in accordance with paragraph 1.

8. The application of Articles 40a to 40g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 13 on the territory of the Member State concerned.

Article 40 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider that instruments which comply with the relevant international standards any national standards in force in the Member State of manufacture, ensuring the safety level equivalent to that required by the essential requirements set out in Annex I, comply with those essential requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex I to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 or

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 40 - e Adoption of common specifications conferring a presumption of conformity

1. Where instruments, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts with respect to such instruments establishing common specifications to cover the essential requirements set out in Annex I in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I of this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 41(3). They shall apply to instruments placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 12, instruments which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 40a(3), first subparagraph, unless there is sufficient reason to believe that the instruments covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the instruments in compliance with the said common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 40 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Annex I for instruments, which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 41(3). They shall apply to for instruments placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act. 

3. By way of derogation from Article 40a(3), first subparagraph, unless there is sufficient reason to believe that the instruments covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the instruments in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 40 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for instruments, designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for instruments, designated as crisis-relevant goods.’

Article 9 - Amendments to Directive 2014/32/EU

In Directive 2014/32/EU, the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 45 - a Application of emergency procedures, and their deactivation

1. Member States shall ensure that measures taken to transpose Articles 45b to 45g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 45b to 45g apply exclusively to measuring instruments, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 45b to 45g apply during the Single Market emergency mode. 

However, Article 45c(2), second subparagraph, and Article 45c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to measuring instruments placed on the market in accordance with Articles 45c to 45f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).

Article 45 - b Prioritisation of the conformity assessment of crisis-relevant measuring instruments

1. This Article shall apply to all measuring instruments designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 17requiring the mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of measuring instruments designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such measuring instruments shall be processed as a matter of priority, ahead of any other applications for conformity assessment of measuring instruments, which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of measuring instruments designated as crisis-relevantrelevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 45a.

4. The prioritisation of applications for conformity assessment of measuring instruments pursuant to paragraph 2 and 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for measuring instruments designated as crisis-relevant goods in respect to which they have been notified.

Article 45 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 17, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into use within the territory of the Member State concerned, of a specific measuring instrument which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in Article 17 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

2. The manufacturer of a measuring instrument subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the measuring instrument concerned complies with all the applicable essential requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the measuring instrument, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the measuring instrument may be placed on the market or put into use, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the measuring instrument concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the measuring instrument concerned;

(e)measures to be taken with respect to the measuring instrument concerned upon expiry of the authorisation in order to ensure that the measuring instrument concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Articles 7 and 20, measuring instruments, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking, nor the supplementary metrology marking.

5. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such measuring instruments.

6. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market and/or putting into use of a measuring instrument in accordance with paragraph 1.

7. The application of Articles 45a to 45g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 17 on the territory of the Member State concerned.

Article 45 - d Presumption of conformity based on national and international standards

Where either:

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into use, their competent authorities consider that the measuring instruments which comply with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential requirements set out in the relevant instrument-specific Annexes, comply with those essential requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex I and in the relevant instrument-specific Annexes to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I and in the relevant instrument-specific Annexes to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 45 - e Adoption of common specifications conferring a presumption of conformity

1. Where measuring instruments have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such measuring instruments to cover the essential requirements set out in Annex I and in the relevant instrument-specific Annexes in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex I and in the relevant instrument-specific Annexes has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)the severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I and in the relevant instrument-specific Annexes to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 46(3). They shall remain apply to measuring instruments placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 14, measuring instruments which are in conformity with common specifications adopted pursuant to paragraph 2 shall be presumed to be in conformity with the essential requirements set out in Annex I and in the relevant instrument-specific Annexes covered by those common specifications or parts thereof.

4. By way of derogation from Article 45a(3), first subparagraph, unless there is sufficient reason to believe that the measuring instruments covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the measuring instruments in compliance with the said common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential requirements which it aims to cover and which are set out in Annex I and in the relevant instrument-specific Annexes, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 45 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Annex I and in the instrument-specific Annexes for measuring instruments, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 46(3).They shall apply to measuring instruments placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 45a(3), first subparagraph, nnless there is sufficient reason to believe that the measuring instruments covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the measuring instruments in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 45 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for measuring instruments, designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for measuring instruments, designated as crisis-relevant goods.’

Article 10 - Amendments to Directive 2014/33/EU

In Directive 2014/33/EU, the following Chapter Va is inserted:

‘CHAPTER Va
EMERGENCY PROCEDURES

Article 41 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 41b to 41g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 41b to 41g apply exclusively to lifts and safety components for lifts, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 41b to 41g apply during the Single Market emergency mode. 

However, Article 41c(3), second subparagraph, and Article 41c(6) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to lifts and safety components for lifts placed on the market in accordance with Articles 41c to 41f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).

Article 41 - b Prioritisation of the conformity assessment of crisis-relevant lifts and safety components for lifts

1. This Article shall apply to all lifts and safety components for lifts designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Articles 15 and 16requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of lifts and safety components for lifts designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such lifts and safety components for lifts shall be processed as a matter of priority, ahead of any other applications for conformity assessment of lifts and safety components for lifts which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of lifts and safety components for lifts designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 41a.

4. The prioritisation of applications for conformity assessment of lifts and safety components for lifts pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for lifts and safety components for lifts designated as crisis-relevant goods in respect to which they have been notified.

Article 41 - c Derogation from party conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 15, any competent national authority may authorise, on a duly justified request, the making available or putting into service within the territory of the Member State concerned, of a specific safety component for lifts which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated.

2. By way of derogation from Article 16, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific lift which has been designated as crisis-relevant good and for which the third-party conformity assessment procedures requiring mandatory involvement of a notified body referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated.

3. The manufacturer of a lift or a safety component for lifts subject to the authorisation procedures referred to in paragraphs 1 or 2 shall declare on his sole responsibility that the lift or the safety component for lifts concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the lift or the safety component for lifts, which has been granted an authorisation pursuant to paragraphs 1 or 2 does not leave the territory of the Member State, which has granted the authorisation.

4. Any authorisation issued by a national competent authority pursuant to paragraphs 1 or 2 shall set out the conditions and requirements under which the lift or a the safety component for lifts may be placed on the market, made available or put into service respectively, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the lift or safety component for lifts concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the lift or safety component for lifts concerned;

(e)measures to be taken with respect to the lift or safety component for lifts concerned upon expiry of the authorisation in order to ensure that the lift or safety component for lifts concerned is brought back in compliance with all the requirements of this Directive.

5. By way of derogation from Article 41a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 4 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

6. By way of derogation from Articles 3 and 19, lifts or safety components for lifts, for which an authorisation has been granted in accordance with paragraphs 1 or 2 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

7. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such lifts or safety components for lifts.

8. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market, making available or putting into service respectively of a lift or a safety component for lifts in accordance with paragraphs 1 or 2.

9. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 15 or 16 on the territory of the Member State concerned.

Article 41 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, making available or putting into service respectively, their competent authorities consider that the lifts and safety components of lifts which comply with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential health and safety requirements set out in Annex I, comply with those essential health and safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where the severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 41 - e Adoption of common specifications conferring a presumption of conformity

1. Where lifts and safety components for lifts, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such lifts and safety components for lifts to cover the essential health and safety requirements set out in Annex I in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 42(3). They shall apply to lifts and safety components for lifts placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 14, lifts and safety components for lifts which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential health and safety requirements set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the lifts and safety components for lifts covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the lifts and safety components for lifts in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential health and safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 41 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential health and safety requirements set out in Annex I for lifts and safety components for lifts, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 42(3) and they shall apply to lifts and safety components for lifts placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the lifts and safety components for lifts covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the lifts and safety components for lifts in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 41 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for lifts and safety components for lifts designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for lifts and safety components for lifts designated as crisis-relevant goods.’

Article 11 - Amendments to Directive 2014/34/EU

In Directive 2014/34/EU, the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 38 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 38b to 38g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply exclusively to products, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply during the Single Market emergency mode. 

However, Article 38c(2), second subparagraph, and Article 38c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to products placed on the market in accordance with Articles 38c to 38f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 39(3).

Article 38 - b Prioritisation of the conformity assessment of crisis-relevant products

1. This Article shall apply to all products designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 13 requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of products designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such equipment products be processed as a matter of priority, ahead of any other applications for conformity assessment of products, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of products designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 38a.

4. The prioritisation of applications for conformity assessment of products pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for products designated as crisis-relevant goods in respect to which they have been notified.

Article 38 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 13, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific product which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated.

2. The manufacturer of a product subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the product concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the product, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the product may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the product concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the product concerned;

(e)measures to be taken with respect to the product concerned upon expiry of the authorisation in order to ensure that the product concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 38a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 5 and 16, products, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such products.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a product in accordance with paragraph 1.

8. The application of Articles 38a to 38g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 13 on the territory of the Member State concerned.

Article 38 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into service, their competent authorities consider that the products which comply with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential health and safety requirements set out in Annex II comply with those essential health and safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 38 - e Adoption of common specifications conferring a presumption of conformity

1. Where products, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such products to cover the essential health and safety requirements set out in Annex II in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 39(3). They shall apply to products placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 12, products which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those common specifications or parts thereof.

4. By way of derogation from Article 38a(3), first subparagraph, unless there is sufficient reason to believe that the products covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the products in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential health and safety requirements which it aims to cover and which are set out in Annex II, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 38 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential health and safety requirements set out in Annex II for products, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 39(3). They shall apply to products placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 38a(3), first subparagraph, unless there is sufficient reason to believe that the products covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the products in compliance with the said common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 38 - g Prioritisation of market surveillance activities and mutual assistance among authorities

Member States shall prioritise the market surveillance activities for products designated as crisis-relevant goods.

1. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for products designated as crisis-relevant goods.’

Article 12 - Amendments to Directive 2014/35/EU

In Directive 2014/35/EU, the following Chapter 4a is inserted:

‘‘CHAPTER 4a
EMERGENCY PROCEDURES

Article 22 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 22b to 22c and 22d of this Directive l only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 22b, 22c and 22d apply exclusively to electrical equipment, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 22b, 22c and 22d apply during the Single Market emergency mode.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to electrical equipment placed on the market in accordance with Articles 22b and 22c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).

Article 22 - b Adoption of common specifications conferring a presumption of conformity

1. Where electrical equipment, has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such electrical equipment to cover the safety objectives referred to in Article 3 and set out in Annex I in either of the following cases:

(a)where no reference to harmonised standards covering the safety objective set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the safety objectives referred to in Article 3 and set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 23(2). They shall apply to electrical equipment placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union lgislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Articles 12, 13 and 14, electrical equipment which is in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the safety objectives referred to in Article 3 and set out in Annex I covered by those common specifications or parts thereof.

4. By way of derogation from Article 22a(3), unless there is sufficient reason to believe that the electrical equipment covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the electrical equipment in compliance with those common specifications which has been placed on the market, shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the safety objectives referred to in Article 3 and set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 22 - c Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the safety objectives referred to in Article 3 and set out in Annex I for electrical equipment, which has been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article, shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 23(2). They shall apply to electrical equipment placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 22a(3), unless there is sufficient reason to believe that the electrical equipment covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the electrical equipment in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 22 - d Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for electrical equipment designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for electrical equipment designated as crisis-relevant goods.’

Article 13 - Amendments to Directive 2014/53/EU

In Directive 2014/53/EU, the following Chapter 5a is inserted:

‘‘CHAPTER Va
EMERGENCY PROCEDURES

Article 43 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 43b to 43g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 43b to 43g apply exclusively to radio equipment, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 43b to 43g apply during the Single Market emergency mode. 

However, Article 43c(2), second subparagraph, and Article 43c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to radio equipment placed on the market in accordance with Articles 43c to 43f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

Article 43 - b Prioritisation of the conformity assessment of crisis-relevant radio equipment

1. This Article shall apply to all radio equipment designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 17 requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of radio equipment designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such radio equipment shall be processed as a matter of priority, ahead of any other applications for conformity assessment of radio equipment, which has not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of radio equipment designated as crisis-relevantgood, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

4. The prioritisation of applications for conformity assessment of radio equipment pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for radio equipment designated as crisis-relevant goods in respect to which they have been notified.

Article 43 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 17, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of specific radio equipment which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

2. The manufacturer of radio equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the radio equipment concerned complies with all the applicable essential requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer, the importer and the distributor shall also deploy all reasonable measures to ensure that the radio equipment, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the radio equipment may be placed on the market, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the radio equipment concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the radio equipment concerned;

(e)measures to be taken with respect to the radio equipment concerned upon expiry of the authorisation in order to ensure that the radio equipment concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Articles 9 and 20, radio equipment, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

5. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such radio equipment.

6. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of radio equipment in accordance with paragraph 1.

7. The application of Articles 43a to 43g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 17 on the territory of the Member State concerned.

Article 43 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider that the radio equipment which complies with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential requirements set out in Article 3, complies with those essential requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Article 3 of this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Article 3 of this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 025/2012.Article 43e
Adoption of common specifications conferring a presumption of conformity

1. Where radio equipment, has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such radio equipment to cover the essential requirements set out in Article 3 in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Article 3 has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Article 3 of this Article and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 45(3). They shall apply to radio equipment placed on the market until the last day of the period for which the Single Market emergency remains active. In the early preparation of the draft implementing acts establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 16, radio equipment which is in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential requirements set out in Article 3 covered by those common specifications or parts thereof.

4. By way of derogation from Article 43a(3), first subparagraph, nnless there is sufficient reason to believe that the radio equipment covered by the common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the radio equipment in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation]

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential requirements which it aims to cover and which are set out in Article 3, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 43 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Article 3 for radio equipment, which has been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 45(3) and they shall apply to radio equipment placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 43a(3), first subparagraph, unless there is sufficient reason to believe that the radio equipment covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the radio equipment in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 43 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for radio equipment designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for radio equipment designated as crisis-relevant goods.’

Article 15 - Amendments to Directive 2014/68/EU

In Directive 2014/68/EU, the following Chapter 5a is inserted:

‘‘CHAPTER 5a
EMERGENCY PROCEDURES

Article 43 - a Application of emergency procedures,

1. Member States shall ensure that measures taken to transpose Articles 43b to 43g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Directive.

2. Member States shall ensure that measures taken to transpose Articles 43b to 43g apply exclusively to pressure equipment and assemblies, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Member States shall ensure that measures taken to transpose Articles 43b to 43g apply during the Single Market emergency mode.

However, Article 43c(2), second subparagraph, and Article 17c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to pressure equipment and assemblies placed on the market in accordance with Articles 43c to 43f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

Article 43 - b Prioritisation of the conformity assessment of crisis-relevant pressure equipment and assemblies

1. This Article shall apply to pressure equipment or assemblies designated as crisis-relevant goods, which are subject to conformity assessment procedures, which require the mandatory involvement of a notified body, in accordance with Article 14.

2. The notified bodies shall process all applications for conformity assessment of pressure equipment and assemblies designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such in accordance with Article 14shall be processed as a matter of priority, ahead of any other applications for conformity assessment of pressure equipment or assemblies, which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of pressure equipment and assemblies designated as crisis-relevant goods, irrespective of whether they have beenlodged before or after the activation of the emergency procedures pursuant to Article 43a.

4. The prioritisation of applications for conformity assessment of pressure equipment and assemblies pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for pressure equipment and assemblies designated as crisis-relevant goods in respect of which they have been notified.

Article 43 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 14, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of specific pressure equipment or assembly designated as crisis-relevant good and for which the conformity assessment procedures referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

2. The manufacturer of pressure equipment or assembly subject to the authorisation procedure referred to in paragraph 1 of this Article shall declare on his sole responsibility that the pressure equipment or assembly concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the pressure equipment or assembly, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, issued the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the pressure equipment or assembly may be placed on the market or put into service, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements of this Directive was successfully demonstrated;

(b)specific requirements regarding the traceability of the pressure equipment or assembly concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the pressure equipment or assembly concerned;

(e)measures to be taken with respect to the pressure equipment or assembly concerned upon expiry of the authorisation in order to ensure that the pressure equipment or assembly concerned is brought back in compliance with all the requirements of this Directive.

4. By way of derogation from Article 43a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 5 and 19, pressure equipment or assemblies, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such pressure equipment or assemblies.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of a pressure equipment or assembly in accordance with paragraph 1.

8. The application of Articles 43a to 43g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 14 on the territory of the Member State concerned.

Article 43 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider that the pressure equipment or assemblies which comply with relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential safety requirements set out in Annex II, comply with those essential safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 43 - e Adoption of common specifications conferring a presumption of conformity

1. Where pressure equipment and assemblies have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts for such pressure equipment and assemblies establishing common specifications to cover the essential safety requirements set out in Annex II in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Directive shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3). They shall apply to the pressure equipment and assemblies placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 12, pressure equipment or assemblies which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential safety requirements set out in Annex II covered by those common specifications or parts thereof.

4. By way of derogation from Article 43a(3), first subparagraph, nnless there is sufficient reason to believe that the pressure equipment and assemblies covered by the common specifications referred to in paragraph 1 of this Articlepresent a risk to the health or safety of persons, the pressure equipment and assemblies in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 43 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential safety requirements set out in Annex II, ffor pressure equipment or assemblies, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3). They shall apply to pressure equipment and assemblies placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing acts establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 43a(3), first subparagraph, nnless there is sufficient reason to believe that the pressure equipment and assemblies covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the pressure equipment and assemblies in compliance with the said common specifications which have been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 43 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for pressure equipment and assemblies designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for pressure equipment and assemblies designated as crisis-relevant goods.’

Article 15 - Transposition

1. Member States shall adopt and publish, by [OP – please insert date – 6 months after entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

2. They shall apply those provisions from […[ OP please add date – 6 months after the date of entry into force of this Directive].

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 16 - Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 17 - Addressees

This Directive is addressed to the Member States.