Directive 2004/22/EC of the European Parliament and of the Council

of 31 March 2004

on measuring instruments

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission(1),

Having regard to the Opinion of the European Economic and Social Committee(2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

(1) A number of measuring instruments are covered by specific Directives, adopted on the basis of Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control(4). Specific Directives that are technically outdated should be repealed and replaced by an independent Directive reflecting the spirit of the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(5).

(2) Correct and traceable measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, public health, safety and order, protection of the environment and the consumer, of levying taxes and duties and of fair trading, which directly and indirectly affect the daily life of citizens in many ways, may require the use of legally controlled measuring instruments.

(3) Legal metrological control should not lead to barriers to the free movement of measuring instruments. The provisions concerned should be the same in all Member States and proof of conformity accepted throughout the Community.

(4) Legal metrological control requires conformity with specified performance requirements. The performance requirements that the measuring instruments must meet should provide a high level of protection. The conformity assessment should provide a high level of confidence.

(5) Member States should as a general rule prescribe legal metrological control. Where legal metrological control is prescribed, only measuring instruments complying with common performance requirements should be used.

(6) The principle of optionality introduced by this Directive, whereby Member States may exercise their right to decide whether or not to regulate any of the instruments covered by this Directive, should be applicable only to the extent that this will not cause unfair competition.

(7) The responsibilities of the manufacturer for compliance with the requirements of this Directive should be specifically stated.

(8) The performance of measuring instruments is particularly sensitive to the environment, particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference forms an integral part of this Directive and the immunity requirements of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility(6) should therefore not apply.

(9) Community legislation should specify essential requirements that do not impede technical progress, preferably performance requirements. Provisions to remove technical barriers to trade should follow the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards.

(10) In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, essential requirements may give rise to the establishment of environmental or accuracy classes.

(11) In order to ease the task of proving conformity with the essential requirements and to enable conformity to be assessed, it is desirable to have harmonised standards. Such harmonised standards are drawn up by private-law bodies and should retain their status as non-mandatory texts. To this end, the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines on cooperation between the Commission and the European Standardisation bodies signed on 13 November 1984.

(12) The technical and performance specifications of internationally agreed normative documents may also comply, in part or in full, with the essential requirements laid down by this Directive. In those cases the use of these internationally agreed normative documents can be an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity.

(13) Conformity with the essential requirements laid down by this Directive can also be provided by specifications that are not supplied by a European technical standard or an internationally agreed normative document. The use of European technical standards or internationally agreed normative documents should therefore be optional.

(14) The conformity assessment of sub-assemblies should respect the provisions of this Directive. If sub-assemblies are traded separately and independently of an instrument, the exercise of conformity assessment should be undertaken independently of the instrument concerned.

(15) The state of the art in measurement technology is subject to constant evolution which may lead to changes in the needs for conformity assessments. Therefore, for each category of measurement and, where appropriate, sub-assemblies, there must be an appropriate procedure or a choice between different procedures of equivalent stringency. The procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the "CE" marking, which are intended to be used in the technical harmonisation Directives(7). However, derogations may have to be made for these modules in order to reflect specific aspects of metrological control. Provision should be made for the "CE" marking to be affixed during the fabrication process.

(16) Continued development in measurement technology as well as concerns expressed by stakeholders about certification, stress the need to ensure consistent conformity assessment procedures for industrial products, as requested by the Council Resolution adopted on 10 November 2003(8).

(17) Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the "CE" marking and supplementary metrology marking in accordance with the provisions of this Directive.

(18) Member States should take appropriate action to prevent non-complying measuring instruments from being placed on the market and/or put into use. Adequate cooperation between the competent authorities of the Member States is therefore necessary to ensure a Community-wide effect of this objective.

(19) Manufacturers should be informed of the grounds on which negative decisions in respect of their products were taken, and of the legal remedies available to them.

(20) Manufacturers should be offered the possibility to exercise the rights obtained before the entry into force of this Directive, during a reasonable transitional period.

(21) National specifications concerning the appropriate national requirements in use should not interfere with the provisions of this Directive on "putting into use".

(22) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).

(23) The activity of the Measuring Instruments Commmittee should include proper consultations with representatives of interested parties.

(24) Directives 71/318/EEC, 71/319/EEC, 71/348/EEC, 73/362/EEC, 75/33/EEC, as concerns the meters defined in Annex MI-001 of this Directive, 75/410/EEC, 76/891/EEC, 77/95/EEC, 77/313/EEC, 78/1031/EEC and 79/830/EEC should therefore be repealed,

HAVE ADOPTED THIS DIRECTIVE:

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.

Done at Strasbourg, 31 March 2004.

For the European Parliament

The President

P. Cox

For the Council

The President

D. Roche

(1) OJ C 62 E, 27.2.2001, p. 1, and OJ C 126 E, 28.5.2002, p. 368.

(2) OJ C 139, 11.5.2001, p. 4.

(3) Opinion of the European Parliament of 3 July 2001 (OJ C 65 E, 14.3.2002, p. 34). Council Common Position of 22 July 2003 (OJ C 252 E, 21.10.2003, p. 1) and Position of the European Parliament of 17 December 2003 (not yet published in the Official Journal). Decision of the Council of 26 February 2004.

(4) OJ L 202, 6.9.1971, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

(5) OJ C 136, 4.6.1985, p. 1.

(6) OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).

(7) OJ L 220, 30.8.1993, p. 23.

(8) OJ C 282, 25.11.2003, p. 3.

(9) OJ L 184, 17.7.1999, p. 23.

(10) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).

(11) OJ L 202, 6.9.1971, p. 21. Directive as last amended by Commission Directive 82/623/EEC (OJ L 252, 27.8.1982, p. 5).

(12) OJ L 202, 6.9.1971, p. 32.

(13) OJ L 239, 25.10.1971, p. 9. Directive as last amended by the 1994 Act of Accession.

(14) OJ L 335, 5.12.1973, p. 56. Directive as last amended by Commission Directive 85/146/EEC (OJ L 54, 23.2.1985, p. 29).

(15) OJ L 14, 20.1.1975, p. 1.

(16) OJ L 183, 14.7.1975, p. 25.

(17) OJ L 336, 4.12.1976, p. 30.

(18) OJ L 26, 31.1.1977, p. 59.

(19) OJ L 105, 28.4.1977, p. 18. Directive as amended by Commission Directive 82/625/EEC (OJ L 252, 27.8.1982, p. 10).

(20) OJ L 364, 27.12.1978, p. 1.

(21) OJ L 259, 15.10.1979, p. 1.

ANNEX I

ESSENTIAL REQUIREMENTS

A measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data.

The requirements that shall be met by measuring instruments are set out below and are supplemented, where appropriate, by specific instrument requirements in Annexes MI-001 to MI-010 that provide more detail on certain aspects of the general requirements.

The solutions adopted in the pursuit of the requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof.

DEFINITIONS

Measurand The measurand is the particular quantity subject to measurement.

Influence quantity An influence quantity is a quantity that is not the measurand but that affects the result of measurement.

Rated Operating Conditions The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument.

Disturbance An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.

Critical change value The critical change value is the value at which the change in the measurement result is considered undesirable.

Material Measure A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity.

Direct sales A trading transaction is direct sales if:

- the measurement result serves as the basis for the price to pay and;

- at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection and;

- all the parties in the transaction accept the measurement result at that time and place.

Climatic environments Climatic environments are the conditions in which measuring instruments may be used. To cope with climatic differences between the Member States, a range of temperature limits has been defined.

Utility A utility is regarded as a supplier of electricity, gas, heat or water.

REQUIREMENTS

1. Allowable Errors

1.1. Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements.

Unless stated otherwise in the instrument-specific annexes, MPE is expressed as a bilateral value of the deviation from the true measurement value.

1.2. Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements.

Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.

1.3. The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific annexes.

1.3.1. Climatic environments

The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in the Annexes MI-001 to MI-010, and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.

Table 1

>TABLE>

1.3.2. (a) Mechanical environments are classified into classes M1 to M3 as described below.

M1 This class applies to instruments used in locations with vibration and shocks of low significance, e.g. for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, slamming doors, etc.

M2 This class applies to instruments used in locations with significant or high levels of vibration and shock, e.g. transmitted from machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc.

M3 This class applies to instruments used in locations where the level of vibration and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc.

(b) The following influence quantities shall be considered in relation with mechanical environments:

- Vibration;

- Mechanical shock.

1.3.3. (a) Electromagnetic environments are classified into classes E1, E2 or E3 as described below, unless otherwise laid down in the appropriate instrument-specific annexes.

E1 This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.

E2 This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.

E3 This class applies to instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements:

- voltage reductions caused by energising the starter-motor circuits of internal combustion engines,

- load dump transients occurring in the event of a discharged battery being disconnected while the engine is running.

(b) The following influence quantities shall be considered in relation with electromagnetic environments:

- Voltage interruptions,

- Short voltage reductions,

- Voltage transients on supply lines and/or signal lines,

- Electrostatic discharges,

- Radio frequency electromagnetic fields,

- Conducted radio frequency electromagnetic fields on supply lines and/or signal lines,

- Surges on supply lines and/or signal lines.

1.3.4. Other influence quantities to be considered, where appropriate, are:

- Voltage variation,

- Mains frequency variation,

- Power frequency magnetic fields,

- Any other quantity likely to influence in a significant way the accuracy of the instrument.

1.4. When carrying out the tests as envisaged in this Directive, the following paragraphs apply:

1.4.1. Basic rules for testing and the determination of errors

Essential requirements specified in 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific annex, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value.

Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur.

1.4.2. Ambient humidity

- According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate.

- The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate.

2. Reproducibility

The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

3. Repeatability

The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

4. Discrimination and Sensitivity

A measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.

5. Durability

A measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended.

6. Reliability

A measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.

7. Suitability

7.1. A measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.

7.2. A measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.

7.3. The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased.

7.4. Where a measuring instrument is designed for the measurement of values of the measurand that are constant over time, the measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.

7.5. A measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.

7.6. A measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.

When a measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.

8. Protection against corruption

8.1. The metrological characteristics of a measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the measuring instrument.

8.2. A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.

8.3. Software that is critical for metrological characteristics shall be identified as such and shall be secured.

Software identification shall be easily provided by the measuring instrument.

Evidence of an intervention shall be available for a reasonable period of time.

8.4. Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

8.5. For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use.

9. Information to be borne by and to accompany the instrument

9.1. A measuring instrument shall bear the following inscriptions:

- manufacturer's mark or name;

- information in respect of its accuracy,

plus, when applicable:

- information in respect of the conditions of use;

- measuring capacity;

- measuring range;

- identity marking;

- number of the EC-type examination certificate or the EC design examination certificate;

- information whether or not additional devices providing metrological results comply with the provisions of this Directive on legal metrological control.

9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of this Directive suitably marked.

9.3. The instrument shall be accompanied by information on its operation, unless the simplicity of the measuring instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant:

- rated operating conditions;

- mechanical and electromagnetic environment classes;

- the upper and lower temperature limit, whether condensation is possible or not, open or closed location;

- instructions for installation, maintenance, repairs, permissible adjustments;

- instructions for correct operation and any special conditions of use;

- conditions for compatibility with interfaces, sub-assemblies or measuring instruments.

9.4. Groups of identical measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals.

9.5. Unless specified otherwise in an instrument-specific annex, the scale interval for a measured value shall be in the form 1×10n, 2×10n, or 5×10n, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

9.6. A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used.

9.7. The units of measurement used and their symbols shall be in accordance with the provisions of Community legislation on units of measurement and their symbols.

9.8. All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.

10. Indication of result

10.1. Indication of the result shall be by means of a display or hard copy.

10.2. The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.

10.3. In the case of hard copy the print or record shall also be easily legible and non-erasable.

10.4. A measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of this Directive shall bear an appropriate restrictive information.

10.5. Whether or not a measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrologically controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay.

11. Further processing of data to conclude the trading transaction

11.1. A measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when:

- the measurement is non-repeatable and;

- the measuring instrument is normally intended for use in the absence of one of the trading parties.

11.2. Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.

12. Conformity evaluation

A measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of this Directive.

ANNEX A

DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL

1. The "declaration of conformity based on internal production control" is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the appropriate requirements of this Directive.

Written declaration of conformity

5.1. The manufacturer shall affix the "CE" marking and the supplementary metrology marking to each measuring instrument that satisfies the appropriate requirements of this Directive.

5.2. A declaration of conformity is drawn up for an instrument model and shall be kept at the disposal of the national authorities for ten years after the last instrument has been manufactured. It shall identify the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

Authorised representative

6. The manufacturer's obligations contained in paragraphs 3 and 5.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligations contained in paragraphs 3 and 5.2 shall be the responsibility of the person who places the instrument on the market.

ANNEX A1

DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING BY A NOTIFIED BODY

1. "Declaration of conformity based on internal production control plus product testing by a notified body" is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex, and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the appropriate requirements of this Directive.

Product checks

5. A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out in appropriate intervals determined by it, in order to verify the quality of the internal checks of the product, taking into account inter alia the technological complexity of the instruments and the quantity of production. An adequate sample of the final products, taken by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant document(s) referred to in Article 13, or equivalent tests, shall be carried out to check the conformity of the instruments with the appropriate requirements of this Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the notified body shall take appropriate measures.

Written declaration of conformity

6.1. The manufacturer shall affix the "CE" marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 5, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive.

6.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for ten years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

Authorised representative

7. The manufacturer's obligations contained in paragraphs 3 and 6.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligations contained in paragraphs 3 and 6.2 shall be the responsibility of the person who places the instrument on the market.

ANNEX B

TYPE EXAMINATION

1. "Type examination" is the part of a conformity assessment procedure whereby a notified body examines the technical design of a measuring instrument and ensures and declares that the technical design meets the appropriate requirements of this Directive.

2. Type examination may be carried out in either of the following manners. The notified body decides on the appropriate manner and the specimens required:

(a) examination of a specimen, representative of the production envisaged, of the complete measuring instrument;

(b) examination of specimens, representative of the production envisaged, of one or more critical parts of the measuring instrument, plus assessment of the adequacy of the technical design of the other parts of the measuring instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3;

(c) assessment of the adequacy of the technical design of the measuring instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen.

3. The application for type examination shall be lodged by the manufacturer with a notified body of his choice.

The application shall include:

- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition;

- a written declaration that the same application has not been lodged with any other notified body;

- the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument;

- the specimens, representative of the production envisaged, as required by the notified body;

- the supporting evidence for the adequacy of the technical design of those parts of the measuring instrument for which no specimens are required. This supporting evidence shall mention any relevant documents that have been applied, in particular where the relevant documents referred to in Article 13 have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4. The notified body shall:

For the specimens:

4.1. examine the technical documentation, verify that the specimens have been manufactured in conformity with it and identify the elements which have been designed in accordance with the relevant provisions of the relevant documents referred to in Article 13, as well as the elements which have been designed without applying the relevant provisions of those documents;

4.2. carry out the appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant documents referred to in Article 13, these have been applied correctly;

4.3. carry out the appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen not to apply the solutions in the relevant documents referred to in Article 13, the solutions adopted by the manufacturer meet the corresponding essential requirements of this Directive;

4.4. agree with the applicant on the location where the examinations and tests shall be carried out.

For the other parts of the measuring instrument:

4.5. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the measuring instrument.

For the manufacturing process:

4.6. examine the technical documentation to assure that the manufacturer has adequate means to ensure consistent production.

5.1. The notified body shall draw up an evaluation report that records the activities as undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to Article 12(8), the notified body shall release the content of this report, in full or in part, only with the agreement of the manufacturer.

5.2. Where the technical design meets the requirements of this Directive that apply to the measuring instrument, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer and, if appropriate, of his authorised representative, conclusions of the examination, conditions (if any) for its validity and the necessary data for identification of the instrument. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information for conformity evaluation and in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include:

- the metrological characteristics of the type of instrument;

- measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.);

- information on other elements necessary for the identification of the instruments and to check their visual external conformity to type;

- if appropriate, any specific information necessary to verify the characteristics of manufactured instruments;

- in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments.

The certificate shall have a validity of ten years from the date of its issue, and may be renewed for subsequent periods of ten years each.

5.3. The notified body shall establish an evaluation report in this regard and keep it at the disposal of the Member State that designated it.

6. The manufacturer shall inform the notified body that holds the technical documentation concerning the EC-type examination certificate of all modifications to the instrument that may affect the conformity of the instrument with the essential requirements or the conditions for validity of the certificate. Such modifications require additional approval in the form of an addition to the original EC-type examination certificate.

7. Each notified body shall immediately inform the Member State that designated it about:

- EC-type examination certificates and annexes issued;

- additions and amendments relating to certificates already issued.

Each notified body shall immediately inform the Member State that designated it of the withdrawal of an EC-type examination certificate.

The notified body shall hold the technical file including the documentation submitted by the manufacturer for a period up to the end of the validity of the certificate.

8. The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions with the technical documentation for 10 years after the last measuring instrument has been manufactured.

9. The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and carry out the obligations mentioned in paragraphs 6 and 8. Where the manufacturer is not established within the Communities and where he does not have an authorised representative, the obligation to make the technical documentation available on request shall be the responsibility of the person designated by the manufacturer.

ANNEX C

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

1. "Declaration of conformity to type based on internal production control" is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

2. The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the type as described in the EC-type examination certificate and with the appropriate requirements of this Directive.

Written declaration of conformity

3.1. The manufacturer shall affix the "CE" marking and the supplementary metrology marking to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive.

3.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the instrument model for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

Authorised representative

4. The manufacturer's obligations contained in paragraph 3.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligation mentioned in paragraph 3.2 shall be the responsibility of the person who places the instrument on the market.

ANNEX C1

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING BY A NOTIFIED BODY

1. "Declaration of conformity to type based on internal production control plus product testing by a notified body" is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

2. The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the type as described in the EC-type examination certificate and with the appropriate requirements of this Directive.

Product checks

3. A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out in appropriate intervals determined by it, in order to verify the quality of the internal checks of the product, taking into account inter alia the technological complexity of the instruments and the quantity of production. An adequate sample of the final products, taken by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant documents referred to in Article 13, or equivalent tests, shall be carried out to check the conformity of the product with the type as described in the EC-type examination certificate and the appropriate requirements of the Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the notified body shall take appropriate measures.

Written declaration of conformity

4.1. The manufacturer shall affix the "CE" marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3, the latter's identification number, to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive.

4.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

Authorised representative

5. The manufacturer's obligations contained in paragraph 4.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligations mentioned in paragraph 4.2 shall be the responsibility of the person who places the instrument on the market.

ANNEX D

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. "Declaration of conformity to type based on quality assurance of the production process" is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

2. The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instrument concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality system

3.1. The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice.

The application shall include:

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation of the approved type and a copy of the EC-type examination certificate.

3.2. The quality system shall ensure compliance of the instruments with the type as described in the EC-type examination certificate and the appropriate requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

- the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

- the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc;

- the means to monitor the achievement of the required product quality and the effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published.

In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:

- the quality system documentation;

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Written declaration of conformity

5.1. The manufacturer shall affix the "CE" marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive.

5.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

6. The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:

- the documentation referred to in paragraph 3.1, second indent;

- the change referred to in paragraph 3.5, as approved;

- the decisions and reports from the notified body referred to in paragraphs 3.5, 4.3 and 4.4.

7. Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

ANNEX D1

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. "Declaration of conformity based on quality assurance of the production process" is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instrument concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

5.1. The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice.

The application shall include:

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation referred to in paragraph 2.

5.2. The quality system shall ensure compliance of the instruments with the appropriate requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain, in particular, an adequate description of:

- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

- the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

- the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;

- the means to monitor the achievement of the required product quality and the effective operation of the quality system.

5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published.

In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5.5. The manufacturer shall keep the notified body that has approved the quality system periodically informed of any intended change of the quality system.

The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

6.1. The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system.

6.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:

- the quality system documentation;

- the technical documentation referred to in paragraph 2;

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

6.4. Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Written declaration of conformity

7.1. The manufacturer shall affix the "CE" marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 5.1, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive.

7.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

8. The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:

- the documentation referred to in paragraph 5.1, second indent;

- the change referred to in paragraph 5.5, as approved;

- the decisions and reports from the notified body referred to in paragraphs 5.5, 6.3 and 6.4.

9. Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval.

Authorised representative

10. The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7.2 and 8 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

ANNEX E

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF FINAL PRODUCT INSPECTION AND TESTING

1. "Declaration of conformity to type based on quality assurance of final product inspection and testing" is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

2. The manufacturer shall operate an approved quality system as specified in paragraph 3 for final product inspection and testing of the measuring instrument concerned and shall be subject to surveillance, as specified in paragraph 4.

Quality system

3.1. The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice.

The application shall include:

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation of the approved type and a copy of the EC-type examination certificate.

3.2. The quality system shall ensure compliance of the instruments with the type as described in the EC-type examination certificate and the appropriate requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

- the examinations and tests that will be carried out after manufacture;

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;

- the means to monitor the effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published.

In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system.

The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage, and shall provide it with all necessary information, in particular:

- the quality system documentation;

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Written declaration of conformity

5.1. The manufacturer shall affix the "CE" marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive.

5.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the instrument model for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

6. The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:

- the documentation referred to in the second indent of paragraph 3.1;

- the change referred to in the second subparagraph of paragraph 3.5, as approved;

- the decisions and reports from the notified body which are referred to in paragraph 3.5, final subparagraph, paragraph 4.3 and paragraph 4.4.

7. Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.

ANNEX E1

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF FINAL PRODUCT INSPECTION AND TESTING

1. "Declaration of conformity based on quality assurance of final product inspection and testing" is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the appropriate requirements of this Directive.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instrument concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

5.1. The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice.

The application shall include:

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation referred to in paragraph 2.

5.2. The quality system shall ensure compliance of the instruments with the appropriate requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

This documentation shall contain in particular an adequate description of:

- the quality objectives and