Legal provisions of COM(2023)10 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

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dossier COM(2023)10 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices ...
document COM(2023)10 EN
date March 15, 2023

Contents

Article 1

Regulation (EU) 2017/745 is amended as follows:

(1) Article 120 is amended as follows:

(a)in paragraph 2, the second subparagraph is replaced by the following:

‘Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC as from 25 May 2017 that were valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the dates set out in paragraph 3b for the relevant risk class of the devices. Certificates referred to in the first sentence that have expired before [OP please insert the date – date of entry into force of this Regulation] shall be considered to be valid until the dates set out in paragraph 3b only if one of the following conditions is fulfilled:

(a)before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;

(b)a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) or has required the manufacturer, in accordance with Article 97(1), to carry out the applicable conformity assessment procedure’;

(b)paragraph 3 is replaced by the following:

‘3a. By way of derogation from Article 5 and provided the conditions set out in paragraph 3d of this Article are met, devices referred to in paragraphs 3b and 3c of this Article may be placed on the market or put into service until the dates set out in those paragraphs.

3b. Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until the following dates:

(a)31 December 2027, for class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;

(b)31 December 2028, for class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

3c. Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

3d. Devices may be placed on the market or put into service until the dates referred to in paragraphs 3b and 3c of this Article only if the following conditions are met:

(a)those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;

(b)there are no significant changes in the design and intended purpose;

(c)the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

(d)no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);

(e)no later than 26 May 2024, the manufacturer, or an authorised representative, has lodged a formal application in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraphs 3b and 3c of this Article or in respect of a device intended to substitute that device, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.

3e. By way of derogation from paragraph 3a, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3b and 3c of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC.

3f. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in paragraph 3b of this Article shall continue to be responsible for the appropriate surveillance in respect of the applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a notified body designated in accordance with Article 42 that the latter shall carry out that surveillance.

No later than 26 September 2024, the notified body that has signed the written agreement referred to in paragraph 3d, point (e), shall be responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, the surveillance shall be conducted in respect of the device that is being substituted.

The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 42 shall be defined in an agreement between the manufacturer, the notified body designated in accordance with Article 42 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 42 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.

3g. By way of derogation from Article 5, class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8), second subparagraph, provided that no later than 26 May 2024, the manufacturer, or the authorised representative of the manufacturer, has lodged a formal application in accordance with Section 4.3, first subparagraph, of Annex VII for the applicable conformity assessment, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.’;

(c)paragraph 4 is replaced by the following:

‘4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraphs 3a, 3b, 3c and 3g of this Article, may continue to be made available on the market or put into service.’

(2) Article 122 is amended as follows:

(1) in the first paragraph, the introductory wording is replaced by the following:

‘Without prejudice to Article 120(3a) to (3f) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2021, with the exception of:’;

(2) the second paragraph is replaced by the following:

‘As regards the devices referred to in Article 120(3a) to (3f) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply to the extent necessary for the application of those paragraphs.’;

(3) In Article 123(3), point (d), the twenty-fourth indent is replaced by the following:

‘- Article 120(3e).’.

Article 2

Regulation (EU) 2017/746 is amended as follows:

(1) in Article 110, paragraph 4 is replaced by the following:

‘4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service.’;

(2) in Article 112, the second paragraph is replaced by the following:

‘As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs.’.

Article 3

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.