Legal provisions of COM(2000)566 - Measuring instruments

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dossier COM(2000)566 - Measuring instruments.
document COM(2000)566 EN
date March 31, 2004


Contents

Article 1 - Scope

This Directive applies to the devices and systems with a measuring function defined in the instrument-specific annexes concerning water meters (MI-001), gas meters and volume conversion devices (MI-002), active electrical energy meters (MI-003), heat meters (MI-004), measuring systems for continuous and dynamic measurement of quantities of liquids other then water (MI-005), automatic weighing instruments (MI-006), taximeters (MI-007), material measures (MI-008), dimensional measuring instruments (MI-009) and exhaust gas analysers (MI-010).

Article 2

1. Member States may prescribe the use of measuring instruments mentioned in Article 1 for measuring tasks for reasons of public interest, public health, public safety, public order, protection of the environment, protection of consumers, levying of taxes and duties and fair trading, where they consider it justified.

2. Where Member States do not prescribe such use, they shall communicate the reasons therefor to the Commission and the other Member States.

Article 3 - Object

This Directive establishes the requirements that the devices and systems referred to in Article 1 have to satisfy with a view to their being placed on the market and/or put into use for those tasks mentioned in Article 2(1).

This Directive is a specific Directive in respect of requirements for electromagnetic immunity in the sense of Article 2(2) of Directive 89/336/EEC. Directive 89/336/EEC continues to apply with regard to emission requirements.

Article 4 - Definitions

For the purposes of this Directive:

(a) 'measuring instrument' means any device or system with a measurement function that is covered by Articles 1 and 3;

(b) 'sub-assembly' means a hardware device, mentioned as such in the specific annexes, that functions independently and makes up a measuring instrument together

- with other sub-assemblies with which it is compatible, or

- with a measuring instrument with which it is compatible;

(c) 'legal metrological control' means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading;

(d) 'manufacturer' means a natural or legal person responsible for the conformity of the measuring instrument with this Directive with a view to either placing it on the market under his own name and/or putting it into use for his own purposes;

(e) 'placing on the market' means making available for the first time in the Community an instrument intended for an end user, whether for reward or free of charge;

(f) 'putting into use' means the first use of an instrument intended for the end user for the purposes for which it was intended;

(g) 'authorised representative' means a natural or legal person who is established within the Community and authorised by a manufacturer, in writing, to act on his behalf for specified tasks within the meaning of this Directive;

(h) 'harmonised standard' means a technical specification adopted by CEN, CENELEC or ETSI or jointly by two or all of these organisations, at the request of the Commission pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(10) and prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations;

(i) 'normative document' means a document containing technical specifications adopted by the Organisation Internationale de Métrologie Légale (OIML), subject to the procedure stipulated in Article 16(1).

Article 5 - Applicability to sub-assemblies

Where specific annexes exist, laying down the essential requirements for sub-assemblies, the provisions of this Directive shall apply mutatis mutandis to such sub-assemblies.

Sub-assemblies and measuring instruments may be assessed independently and separately for the purpose of establishing conformity.

Article 6 - Essential requirements and assessment of conformity

1. A measuring instrument shall meet the essential requirements laid down in Annex I and in the relevant instrument-specific Annex.

Member States may require, if it is needed for correct use of the instrument, the information referred to in Annex I or in the relevant instrument-specific annexes to be provided in the official language(s) of the Member State in which the instrument is placed on the market.

2. The conformity of a measuring instrument with the essential requirements shall be assessed in accordance with Article 9.

Article 7 - Conformity marking

1. The conformity of a measuring instrument with all the provisions of this Directive shall be indicated by the presence on it of the 'CE' marking and the supplementary metrology marking as specified in Article 17.

2. The 'CE' marking and supplementary metrology marking shall be affixed by, or under the responsibility of, the manufacturer. These markings may be affixed to the instrument during the fabrication process, if justified.

3. The affixing of markings on a measuring instrument that are likely to deceive third parties as to the meaning and/or form of the 'CE' marking and the supplementary metrology marking shall be prohibited. Any other marking may be affixed on a measuring instrument, provided that the visibility and legibility of the 'CE' marking and the supplementary metrology marking is not thereby reduced.

4. Where the measuring instrument is subject to measures adopted under other Directives covering other aspects which require the affixing of the 'CE' marking, the marking shall indicate that the instrument in question is also presumed to conform to the requirements of those other Directives. In such a case, the publication reference of the said Directives, in the Official Journal of the European Union, must be given in the documents, notices or instructions required by those Directives and accompanying the measuring instrument.

Article 8 - Placing on the market and putting into use

1. Member States shall not impede for reasons covered by this Directive the placing on the market and/or putting into use of any measuring instrument that carries the 'CE' marking and supplementary metrology marking in accordance with Article 7.

2. Member States shall take all appropriate measures to ensure that measuring instruments be placed on the market and/or put into use only if they satisfy the requirements of this Directive.

3. A Member State may require a measuring instrument to satisfy provisions governing its putting into use that are justified by local climatic conditions. In such a case, the Member State shall choose appropriate upper and lower temperature limits from Table 1 of Annex I and, in addition, may specify humidity conditions (condensing or non-condensing) and whether the intended location of use is open or closed.

4. When different accuracy classes are defined for a measuring instrument:

(a) the instrument-specific annexes under the heading 'Putting into use' may indicate the accuracy classes to be used for specific applications.

(b) in all other cases a Member State may determine the accuracy classes to be used for specific applications within the classes defined, subject to allowing the use of all accuracy classes on its territory.

In either case falling under (a) or (b), measuring instruments of a better accuracy class may be used if the owner so chooses.

5. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of instruments not in conformity with this Directive, provided that a visible sign clearly indicates their non-conformity and their non-availability for placing on the market and/or putting into use until brought into conformity.

Article 9 - Conformity assessment

Conformity assessment of a measuring instrument with the relevant essential requirements shall be carried out by the application, at the choice of the manufacturer, of one of the conformity assessment procedures listed in the instrument-specific annex. The manufacturer shall provide, where appropriate, technical documentation for specific instruments or groups of instruments as set out in Article 10.

The conformity assessment modules making up the procedures are described in Annexes A to H1.

Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Member State where the notified body carrying out the Conformity assessment procedures is established, or in a language accepted by that body.

Article 10 - Technical Documentation

1. The technical documentation shall render the design, manufacture and operation of the measuring instrument intelligible and shall permit an assessment of its conformity with the appropriate requirements of this Directive.

2. The technical documentation shall be sufficiently detailed to ensure:

- the definition of the metrological characteristics,

- the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and

- the integrity of the instrument.

3. The technical documentation shall include insofar as relevant for assessment and identification of the type and/or instrument:

(a) a general description of the instrument;

(b) conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc;

(c) manufacturing procedures to ensure consistent production;

(d) if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;

(e) descriptions and explanations necessary for the understanding of paragraphs (b), (c) and (d), including the operation of the instrument;

(f) a list of the standards and/or normative documents referred to in Article 13, applied in full or in part;

(g) descriptions of the solutions adopted to meet the essential requirements where the standards and/or normative documents referred to in Article 13 have not been applied;

(h) results of design calculations, examinations, etc;

(i) the appropriate test results, where necessary, to demonstrate that the type and/or instruments comply with:

- the requirements of this Directive under declared rated operating conditions and under specified environmental disturbances,

- the durability specifications for gas-, water-, heat-meters as well as for liquids other than water.

(j) the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design.

4. The manufacturer shall specify where seals and markings have been applied.

5. The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies, where relevant.

Article 11 - Notification

1. Member States shall notify to the other Member States and the Commission the bodies under their jurisdiction, which they have designated to carry out the tasks pertaining to the conformity assessment modules referred to in Article 9, together with the identification numbers given to them by the Commission in accordance with paragraph 4 of this Article, the kind(s) of measuring instrument for which each body has been designated and in addition, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification.

2. Member States shall apply the criteria set out in Article 12 for the designation of such bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to meet the corresponding criteria. Member States shall publish the references to these national standards.

If a Member State has not introduced national legislation for tasks mentioned under Article 2, it shall retain the right to designate and notify a body for tasks relating to that instrument.

3. A Member State that has notified a body shall:

- ensure that the body continues to meet the criteria set out in Article 12,

- withdraw such notification if it finds that the body no longer meets those criteria.

It shall forthwith inform the other Member States and the Commission of any such withdrawal.

4. Each of the bodies to be notified shall be given an identification number by the Commission. The Commission shall publish the list of notified bodies, together with the information in respect of the scope of the notification referred to in paragraph 1, in the Official Journal of the European Union, C series, and shall ensure that the list is kept up to date.

Article 12 - Criteria to be satisfied by designated bodies

Member States shall apply the following criteria for the designation of bodies in accordance with Article 11(1).

1. The body, its director and staff involved in conformity assessment tasks shall not be the designer, manufacturer, supplier, installer or user of the measuring instruments that they inspect, nor the authorised representative of any of them. In addition, they may not be directly involved in the design, manufacture, marketing or maintenance of the instruments, nor represent the parties engaged in these activities. The preceding criterion does not, however, preclude in any way the possibility of exchanges of technical information between the manufacturer and the body for the purposes of conformity assessment.

2. The body, its director and staff involved in conformity assessment tasks shall be free from all pressures and inducements, in particular financial inducements, that might influence their judgement or the results of their conformity assessment, especially from persons or groups of persons with an interest in the results of the assessments.

3. The conformity assessment shall be carried out with the highest degree of professional integrity and requisite competence in the field of metrology. Should the body subcontract specific tasks, it shall first ensure that the subcontractor meets the requirements of this Directive, and in particular of this Article. The body shall keep the relevant documents assessing the subcontractor's qualifications and the work carried out by him under this Directive at the disposal of the notifying authority.

4. The body shall be capable of carrying out all the conformity assessment tasks for which it has been designated, whether those tasks are carried out by the body itself or on its behalf and under its responsibility. It shall have at its disposal the necessary staff and shall have access to the necessary facilities for carrying out in a proper manner the technical and administrative tasks entailed in conformity assessment.

5. The body's staff shall have:

- sound technical and vocational training, covering all conformity assessment tasks for which the body was designated;

- satisfactory knowledge of the rules governing the tasks which it carries out, and adequate experience of such tasks;

- the requisite ability to draw up the certificates, records and reports demonstrating that the tasks have been carried out.

6. The impartiality of the body, its director and staff shall be guaranteed. The remuneration of the body shall not depend on the results of the tasks it carries out. The remuneration of the body's director and staff shall not depend on the number of tasks carried out or on the results of such tasks.

7. The body shall take out civil liability insurance if its civil liability is not covered by the Member State concerned under national law.

8. The body's director and staff shall be bound to observe professional secrecy with regard to all information obtained in the performance of their duties pursuant to this Directive, except vis-à-vis the authority of the Member State which has designated it.

Article 13 - Harmonised standards and normative documents

1. Member States shall presume conformity with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes in respect of a measuring instrument that complies with the elements of the national standards implementing the European harmonised standard for that measuring instrument that correspond to those elements of this European harmonised standard the references in respect of which have been published in the Official Journal of the European Union, C series.

Where a measuring instrument complies only in part with the elements of the national standards referred to in the first subparagraph, Member States shall presume conformity with the essential requirements corresponding to the elements of the national standards with which the instrument complies.

Member States shall publish the references to the national standards referred to in the first subparagraph.

2. Member States shall presume conformity with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes in respect of a measuring instrument that complies with the corresponding parts of the normative documents and lists referred to in Article 16(1)(a), the references in respect of which have been published in the Official Journal of the European Union, C series.

Where a measuring instrument complies only in part with the normative document referred to in the first subparagraph, Member States shall presume conformity with the essential requirements corresponding to the normative elements with which the instrument complies.

Member States shall publish the references of the normative document referred to in the first subparagraph.

3. A manufacturer may choose to use any technical solution that complies with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes (MI-001 to MI-010). In addition, to benefit from the presumption of conformity, the manufacturer must correctly apply solutions mentioned either in the relevant European harmonised standards, or in the corresponding parts of the normative documents and lists as referred to in paragraphs 1 and 2.

4. Member States shall presume compliance with the appropriate tests mentioned in point (i) of Article 10 if the corresponding test programme has been performed in accordance with the relevant documents mentioned in paragraphs 1 to 3 and if the test results ensure compliance with the essential requirements.

Article 14 - Standing Committee

Where a Member State or the Commission considers that a European harmonised standard as referred to in Article 13(1) does not fully meet the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes, the Member State or the Commission shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, giving its reasons for doing so. The Committee shall deliver an opinion without delay.

In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw the references to the national standards from the publication referred to in the third subparagraph of Article 13(1).

Article 15 - Measuring Instruments Committee

1. The Commission shall be assisted by the Measuring Instruments Committee.

2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4. The Committee shall adopt its Rules of Procedure.

5. The Commission shall ensure that relevant information about envisaged measures, as referred to in Article 16, is made available to interested parties in due time.

Article 16 - Functions of the Measuring Instruments Committee

1. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 15(2), may take any appropriate measure to:

(a) identify normative documents drawn up by OIML and, in a list, indicate the parts thereof compliance with which gives rise to a presumption of conformity with the corresponding essential requirements of this Directive;

(b) publish the references of the normative documents and the list referred to in point (a) in the Official Journal of the European Union, C series.

2. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 15(3), may take any appropriate measure to amend instrument-specific annexes (MI-001 to MI-010) in respect of:

- the maximum permissible errors (MPEs) and accuracy classes,

- the rated operating conditions,

- the critical change values,

- disturbances,

3. Where a Member State or the Commission considers that a normative document whose references have been published in the Official Journal of the European Union, C series, in accordance with paragraph 1(b), does not fully meet the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes, that Member State or the Commission shall bring the matter before the Measuring Instruments Committee, giving the reasons for doing so.

The Commission, acting in accordance with the procedure referred to in Article 15(2), shall inform the Member States whether or not it is necessary to withdraw the references to the normative document concerned from publication in the Official Journal.

4. Member States may take appropriate measures to consult interested parties at national level about OIML work relating to the scope of this Directive.

Article 17 - Markings

1. The 'CE' marking referred to in Article 7 consists of the symbol 'CE' according to the design laid down in paragraph I.B(d) of the Annex to Decision 93/465/EEC. The 'CE' marking shall be at least 5 mm high.

2. The supplementary metrology marking consists of the capital letter 'M' and the last two digits of the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the 'CE' marking. The supplementary metrology marking shall immediately follow the 'CE' marking.

3. The identification number of the notified body concerned referred to in Article 11, if prescribed by the conformity assessment procedure, shall follow the 'CE' marking and supplementary metrology marking.

4. When a measuring instrument consists of a set of devices, not being sub-assemblies, operating together, the markings shall be affixed on the instrument's main device.

When a measuring instrument is too small or too sensitive to carry the 'CE' marking and supplementary metrology marking, the markings shall be carried by the packaging, if any, and by the accompanying documents required by this Directive.

5. The 'CE' marking and supplementary metrology marking shall be indelible. The identification number of the notified body concerned shall be indelible or self destructive upon removal. All markings shall be clearly visible or easily accessible.

Article 18 - Market surveillance and administrative cooperation

1. Member States shall take all appropriate measures to ensure that measuring instruments that are subject to legal metrological control but do not comply with applicable provisions of this Directive are neither placed on the market nor put into use.

2. The competent authorities of the Member States shall assist each other in the fulfilment of their obligations to carry out market surveillance.

In particular, the competent authorities shall exchange:

- information concerning the extent to which instruments they examine comply with the provisions of this Directive, and the results of such examinations;

- EC-type examination and design examination certificates and their annexes issued by notified bodies as well as additions, amendments and withdrawals relating to certificates already issued;

- quality system approvals issued by notified bodies, as well as information on quality systems refused or withdrawn;

- evaluation reports established by notified bodies, when demanded by other authorities.

3. The Member States shall ensure that all necessary information relating to the certificates and quality system approvals is made available to bodies they have notified.

4. Each Member State shall inform the other Member States and the Commission which competent authorities it has designated for such exchange of information.

Article 19 - Safeguard clause

1. Where a Member State establishes that all or part of the measuring instruments of a particular model that bear the 'CE' marking and the supplementary metrology marking do not satisfy the essential requirements relating to metrological performance set out in this Directive, when correctly installed and used in accordance with the manufacturer's instructions, it shall take all appropriate measures to withdraw these instruments from the market, prohibit or restrict their further being placed on the market, or prohibit or restrict their further being used.

When deciding on the above measures, the Member State shall take account of the systematic or incidental nature of the non-compliance. Where the Member State has established that the non-compliance is of a systematic nature, it shall immediately inform the Commission of the measures taken, indicating the reasons for its decision.

2. The Commission shall enter into consultation with the parties concerned as soon as possible.

(a) Should the Commission find that the measures taken by the Member State concerned are justified, it shall immediately inform that Member State thereof, as well as the other Member States.

The competent Member State shall take appropriate action against any person who affixed the markings and shall inform the Commission and the other Member States thereof.

If the non-compliance is attributed to shortcomings in the standards or normative documents, the Commission shall, after consulting the parties concerned, bring the matter as soon as possible before the appropriate Committee referred to in Articles 14 or 15.

(b) Should the Commission find that the measures taken by the Member State concerned are not justified, it shall immediately inform that Member State thereof, as well as the manufacturer concerned or his authorised representative.

The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedure.

Article 20 - Unduly fixed markings

1. Where a Member State establishes that the 'CE' marking and supplementary metrology marking have been affixed unduly, the manufacturer or his authorised representative shall be obliged:

- to make the instrument conform as regards those provisions concerning the 'CE' marking and supplementary metrology marking not covered by Article 19(1) and

- to end the infringement under the conditions imposed by the Member State.

2. Should the infringement described above persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market or prohibit or restrict its further use in accordance with the procedures laid down in Article 19.

Article 21 - Decisions entailing refusal or restriction

Any decision taken pursuant to this Directive entailing the withdrawal from the market of a measuring instrument, or prohibiting or restricting the placing on the market or putting into use of an instrument, shall state the exact grounds on which it is based. The decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the law of the Member State concerned and of the time limits to which such remedies are subject.

Article 22 - Repeals

The following Directives shall be repealed as from 30 October 2006 without prejudice to Article 23:

- Council Directive 71/318/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to gas meters(11),

- Directive 71/319/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to meters for liquids other than water(12);

- Directive 71/348/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to ancillary equipment for meters for liquids other than water(13),

- Directive 73/362/EEC of 19 November 1973 on the approximation of the laws of the Member States relating to material measures of length(14),

- Directive 75/33/EEC of 17 December 1974 on the approximation of the laws of the Member States relating to cold water meters, as concerns the meters defined in Annex MI-001 of this Directive(15).

- Directive 75/410/EEC of 24 June 1975 on the approximation of the laws of the Member States relating to continuous totalising weighing machines(16),

- Directive 76/891/EEC of 4 November 1976 on the approximation of the laws of the Member States relating to electrical energy meters(17),

- Directive 77/95/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to taximeters(18),

- Directive 77/313/EEC of 5 April 1977 on the approximation of the laws of the Member States relating to measuring systems for liquids other than water(19),

- Directive 78/1031/EEC of 5 December 1978 on the approximation of the laws of the Member States relating to automatic checkweighing and weight grading machines(20),

- Directive 79/830/EEC of 11 September 1979 on the approximation of the laws of the Member States relating to hot-water meters(21).

Article 23 - Transitional provisions

By way of derogation from Article 8(2), Member States shall permit, for measurement tasks for which they have prescribed the use of a legally controlled measuring instrument, the placing on the market and putting into use of measuring instruments that satisfy the rules applicable before 30 October 2006 until the expiry of the validity of the type approval of those measuring instruments or, in the case of a type approval of indefinite validity, for a period of a maximum of ten years from 30 October 2006.

Article 24 - Transposition

1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 30 April 2006. They shall forthwith inform the Commission thereof.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

Member States shall apply these provisions from 30 October 2006.

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

Article 25 - Revision clause

The European Parliament and the Council invite the Commission to report, before 30 April 2011, on the implementation of this Directive, inter alia, on the basis of reports provided by the Member States, and, where appropriate, to submit a proposal for amendments.

The European Parliament and Council invite the Commission to evaluate whether conformity assessment procedures for industrial products are properly applied and, where appropriate, to propose amendments in order to ensure consistent certification.

Article 26 - Entry into force

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

Article 27 - Addressees

This Directive is addressed to the Member States.