EXPLANATORY MEMORANDUM

1. context of the proposal

General context, reasons for and objectives of this proposal

This proposal is presented in the framework of the implementation of the “goods package” adopted in 2008. It is part of a package of proposals aligning ten product directives to Decision No 768/2008/EC establishing a common framework for the marketing of products.

Union (EU) harmonisation legislation ensuring the free movement of products has contributed considerably to the completion and operation of the Single Market. It is based on a high level of protection and provides economic operators with the means to demonstrate conformity, thus ensuring free movement through trust in the products.

Directive 2004/22 EC is an example of that Union harmonisation legislation, ensuring the free movement of measuring instruments. It sets out essential requirements that measuring instruments must comply with in order to be made available on the EU market. Manufacturers must demonstrate that a measuring instrument has been designed and manufactured in compliance with the essential requirements and affix the CE marking and the M supplementary metrology marking.

Experience with the implementation of Union harmonisation legislation has shown – on a cross-sector scale - certain weaknesses and inconsistencies in the implementation and enforcement of this legislation, leading to

(1) the presence of non-compliant or dangerous products on the market and consequently a certain lack of trust in CE marking

(2) competitive disadvantages for economic operators complying with the legislation as opposed to those circumventing the rules

(3) unequal treatment in the case of non-compliant products and distortion of competition amongst economic operators due to different enforcement practices

(4) differing practices in the designation of conformity assessment bodies by national authorities

(5) problems with the quality of certain notified bodies

Furthermore the regulatory environment has become more and more complex, as frequently several pieces of legislation apply simultaneously to one and the same product. Inconsistencies in these pieces of legislation make it increasingly difficult for economic operators and authorities to correctly interpret and apply that legislation.

To remedy these horizontal shortcomings in Union harmonisation legislation observed across several industrial sectors, the “New Legislative Framework” was adopted in 2008 as part of the goods package. Its objective is to strengthen and complete the existing rules and to improve practical aspects of their application and enforcement. The New Legislative Framework (NLF) consists of two complementary instruments, Regulation (EC) No 765/2008 on accreditation and market surveillance and Decision No 768/2008/EC establishing a common framework for the marketing of products.

The NLF Regulation has introduced rules on accreditation (a tool for the evaluation of competence of conformity assessment bodies) and requirements for the organisation and performance of market surveillance and controls of products from third countries. Since 1 January 2010 these rules apply directly in all Member States.

The NLF Decision sets out a common framework for EU product harmonisation legislation. This framework consists of the provisions which are commonly used in EU product legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard mechanisms, etc). These common provisions have been reinforced to ensure that the directives can be applied and enforced more effectively in practice. New elements, such as obligations on importers, have been introduced, which are crucial for improving the safety of products on the market.

The provisions of the NLF Decision and those of the NLF Regulation are complementary and closely interlinked. The NLF Decision contains the corresponding obligations for economic operators and notified bodies allowing market surveillance authorities and authorities responsible for notified bodies to properly perform the tasks imposed on them by the NLF Regulation and to ensure an effective and consistent enforcement of EU product legislation.

However, unlike the NLF Regulation, the provisions of the NLF Decision are not directly applicable. To ensure that all economic sectors subject to Union harmonisation legislation benefit from the improvements of the NLF, the provisions of the NLF Decision need to be integrated into the existing product legislation.

A survey after the adoption of the goods package in 2008 showed that a majority of Union harmonisation legislation on products was due to be revised within the following 3 years, not only to address the problems observed throughout all sectors but also for sector-specific reasons. Any such revision would automatically include an alignment of the legislation concerned to the NLF Decision since Parliament, Council and Commission have committed themselves to use its provisions as much as possible in future legislation on products in order to further the utmost coherence of the regulatory framework.

For a number of other Union harmonisation directives, including Directive 2004/22/EC no revision for sector-specific problems had been envisaged within this timeframe. To ensure that the problems in relation to non-compliance and notified bodies are nevertheless addressed in these sectors, and for the sake of consistency of the overall regulatory environment on products, it was decided to align these directives within a package to the provisions of the NLF Decision.

Consistency with other policies and objectives of the Union

This initiative is in line with the Single Market Act[1], which has stressed the need to restore consumer confidence in the quality of products on the market and the importance of reinforcing market surveillance.

Furthermore it supports the Commission’s policy on Better Regulation and simplification of the regulatory environment.

2. consultation of interested parties and impact assessment

Consultation of interested parties

The alignment of Directive 2004/22/EC to the NLF Decision has been discussed with national experts responsible for the implementation of this Directive and with other interested stakeholders, as well as in bilateral meetings with industry associations.

From June to October 2010 a public consultation was organised that comprised all the sectors involved in this initiative. It consisted of four targeted questionnaires for economic operators, authorities, notified bodies and users and the Commission services received 300 replies. The results are published at:

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm

In addition to the general consultation a specific SME consultation was carried out. 603 SMEs were consulted through the Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf

The consultation process revealed widespread support for the initiative. There is unanimity on the need to improve market surveillance and the system for assessing and monitoring Notified Bodies. Authorities fully support the exercise because it will strengthen the existing system and improve cooperation at EU level. Industry expects a more level playing field resulting from more effective actions against products that do not comply with the legislation, as well as a simplification effect from the alignment of legislation. Certain concerns were expressed on some obligations which are, however, indispensable for increasing the efficiency of market surveillance. These measures will not entail significant costs for industry, and the benefits resulting from improved market surveillance should by far outweigh the costs.

Collection and use of expertise

The impact assessment for this implementation package has largely built on the impact assessment carried out for the New Legislative Framework. In addition to the expertise collected and analysed in that context, further consultation of sector-specific experts and interest groups, as well as horizontal experts active in the area of technical harmonisation, conformity assessment, accreditation and market surveillance, has taken place.

External expertise was also used to obtain some basic data on the measuring instruments sector. In their evaluation report external experts[2] have estimated that Directive 2004/22/EC applies to around 345 million units of measuring instruments (MIs) sold annually in the European market with a total sales value of around €3.25 billion. The evaluation showed that the quality of market surveillance appears as an important concern of industry and it is an area where most authorities recognise that their effort until recently has been limited. Furthermore, there appear to be inconsistencies among the notified bodies in terms of interpreting the Directive’s requirements and other guidance as well as differing levels of capacity. A subsequent public consultation[3] showed that the evaluation of Directive 2004/22/EC can be deemed to be complete as regards the evaluation and is generally supported by stakeholders as regards its analysis.

The weaknesses remarked in market surveillance and quality of notified bodies will be addressed in part by the alignment of Directive 2004/22/EC to the NLF decision.

Impact assessment

Based on the information collected, the Commission carried out an impact assessment which examined and compared three options.

Option 1 - No changes to the current situation

This option proposes no changes to the current directive and relies exclusively on certain improvements that can be expected from the NLF Regulation.

Option 2 – Alignment to the NLF Decision by non-legislative measures

Option 2 considers the possibility of encouraging a voluntary alignment to the provisions set out in the NLF Decision by, e.g., presenting them as best practices in guidance documents.

Option 3 – Alignment to NLF Decision by legislative measures

This option consists in integrating the provisions of the NLF Decision into the existing directives.

Option 3 was found to be the preferred option because

– it will improve the competitiveness of companies and notified bodies taking their obligations seriously, as opposed to those cheating on the system;

– it will improve the functioning of the internal market by ensuring equal treatment of all economic operators, notably importers and distributors, as well as notified bodies;

– it does not entail significant costs for economic operators and notified bodies; for those who are already acting responsibly, no extra costs or only negligible costs are expected;

– it is considered more effective than option 2: due to the lack of enforceability of option 2 it is questionable that the positive impacts would materialise under that option;

– options 1 and 2 do not provide answers to the problem of inconsistencies in the regulatory framework and therefore have no positive impact on the simplification of the regulatory environment.

3. main elements of the proposal 3.1. Horizontal definitions

The proposal modifies a number of definitions which are commonly used throughout Union harmonisation legislation in order to harmonise their meaning throughout that legislation.

3.2. Obligations of economic operators and traceability requirements

The proposal clarifies the obligations of manufacturers and authorised representatives and introduces obligations for importers and distributors. Importers must verify that the manufacturer has carried out the applicable conformity assessment procedure and has drawn up a technical documentation. They must also make sure with the manufacturer that this technical documentation can be made available to authorities upon request. Furthermore importers must verify that the measuring instruments are correctly marked and accompanied by the instructions and information. They must keep a copy of the Declaration of conformity and indicate their name and address on the product, or where this is not possible on the packaging or the accompanying documentation. Distributors must verify that a measuring instrument bears the CE marking, the name of the manufacturer and of the importer, if relevant, and that it is accompanied by the required documentation and instructions.

Importers and distributors must cooperate with market surveillance authorities and take appropriate actions when they have supplied non-compliant measuring instruments.

Enhanced traceability obligations are introduced for all economic operators. Measuring instruments have to bear the manufacturer’s name and address and a number allowing to identify and link the measuring instrument to its technical documentation. When a measuring instrument is imported, the importer’s name and address must also be on the measuring instrument. Furthermore, every economic operator must be able to identify towards authorities the economic operator who has supplied him with a measuring instrument or to whom he has supplied a measuring instrument.

3.3. Harmonised standards

Compliance with harmonised standards provides for a presumption of conformity with the essential requirements. On 1 June 2011 the Commission adopted a proposal for a Regulation on European Standardisation[4] that sets out a horizontal legal framework for European standardisation. The proposal for the Regulation contains inter alia provisions on standardisation requests from the Commission to the European Standardisation Organisation, on the procedure for objections to harmonised standards and on stakeholder participation in the standardisation process. Consequently the provisions of Directive 2004/22/EC which cover the same aspects have been deleted in this proposal for reasons of legal certainty. The provision conferring presumption of conformity to harmonised standards has been modified to clarify the extent of the presumption of conformity when standards only partially cover the essential requirements.

3.4. Conformity assessment and CE marking

Directive 2004/22/EC has selected the appropriate conformity assessment procedures which manufacturers have to apply in order to demonstrate that their measuring instruments comply with the essential requirements. The proposal aligns these procedures to their updated versions set out in the NLF Decision. It also keeps some sector specific elements already provided for in Directive 2004/22/EC such as the mandatory metrology M marking in addition to the CE marking.

General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while the detailed provisions on the affixing of the CE marking and the M marking to measuring instruments have been inserted in this proposal.

3.5. Notified Bodies

The proposal reinforces the notification criteria for notified bodies. It clarifies that subsidiaries or subcontractors must also comply with the notification requirements. Specific requirements for notifying authorities are introduced, and the procedure for notification of notified bodies is revised. The competence of a notified body must be demonstrated by an accreditation certificate. Where accreditation has not been used to evaluate the competence of a notified body, the notification must comprise the documentation demonstrating how the competence of that body has been evaluated. Member States will have the possibility to object to a notification.

3.6. Market surveillance and the safeguard clause procedure

The proposal revises the existing safeguard clause procedure. It introduces a phase of information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant measuring instrument is found. A real safeguard clause procedure - leading to a Decision at Commission level on whether a measure is justified or not - is only launched when another Member State objects to a measure taken against a measuring instrument. Where there is no disagreement on the restrictive measure taken, all Member States must take the appropriate action on their territory.

3.7. Comitology and Delegated acts

The provisions on the operation of the Measuring Instruments Committee have been adapted to the new rules on delegated acts laid down in Article 290 of the Treaty on the Functioning of the EU and to the new provisions on implementing acts laid down in Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers[5].

4. legal elements of the proposal

Legal basis

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union.

Subsidiarity principle

The internal market is a competence that is shared between the Union and the Member States. The subsidiarity principle arises in particular with regard to the newly added provisions aiming at the improvement of effective enforcement of Directive 2004/22/EC, namely, the importer and distributor obligations, the traceability provisions, the provisions on the assessment and notification of notified bodies, and the enhanced cooperation obligations in the context of the revised market surveillance and safeguard procedures.

Experience with the enforcement of the legislation has shown that measures taken at national level have led to divergent approaches and to a different treatment of economic operators inside the EU, which undermines the objective of this directive. If actions are taken at national level to address the problems, this risks creating obstacles to the free movement of goods. Furthermore action at national level is limited to the territorial competence of a Member State. In view of the increasing internationalisation of trade, the number of cross-border cases is constantly rising. Coordinated action at EU level can much better achieve the objectives set, and will in particular render market surveillance more effective. Hence it is more appropriate to take action at EU level.

As regards the problem of inconsistencies throughout the directives, this is a problem which can only be solved by the EU legislator.

Proportionality

In accordance with the principle of proportionality, the proposed modifications do not go beyond what is necessary to achieve the objectives set.

The new or modified obligations do not impose unnecessary burdens and costs on industry - especially on small and medium sized enterprises - or administrations. Where modifications have been identified to have negative impacts, the analysis of the impacts of the option serves to provide the most proportionate response to the problems identified. A number of modifications concern the improvement of clarity of the existing Directive without introducing new requirements that entail added cost.

Legislative technique used

The alignment to the NLF Decision requires a number of substantive amendments to the provisions of Directive 2004/22/EC. To ensure the readability of the amended text the technique of recasting has been chosen in line with the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts[6].

The changes made to the provisions of Directive 2004/22/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures.

The proposal does not change the scope of Directive 2004/22/EC and the essential requirements.

5. budgetary implications

This proposal does not have any implications for the EU budget.

6. additional information

Repeal of existing legislation

The adoption of the proposal will lead to repeal of Directive 2004/22/EC.

European Economic Area

The proposal concerns the EEA and should therefore be extended to the European Economic Area.

ê 2004/22/EC (adapted)

2011/0353 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the harmonisation of the laws of the Member States relating to making available on the market of measuring instruments

(Recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community Ö on the Functioning of the European Union Õ , and in particular Article 95 Ö 114 Õ thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee[7],

Acting in accordance with the ordinary legislative procedure,

Whereas:

ê 2004/22/EC recital 1 (adapted)

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[8]. 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[9].

ò new

(1) Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments[10] has been substantially amended several times. Since further amendments are to be made, it should be recast in the interests of clarity.

(2) Regulation (EC) No 765/2008/EC of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93[11] lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.

(3) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC[12] lays down a common framework of general principles and reference provisions intended to apply across the legislation harmonising the conditions for the marketing of products in order to provide a coherent basis for revision or recasts of that legislation. Directive 2004/22/EC should therefore be adapted to that Decision.

ê 2004/22/EC recital 2

(4) 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.

ê 2004/22/EC recital 3 (adapted)

(5) 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 Ö Union Õ .

ê 2004/22/EC recital 4

(6) 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.

ê 2004/22/EC recital 5

(7) 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.

ê 2004/22/EC recital 6 (adapted)

(8) The principle of optionality introduced by this Directive Ö 2004/22/EC allows Õ , whereby Member States may Ö to Õ exercise their right to decide whether or not to regulate any Ö prescribe the use Õ of the instruments covered by this Directive, should be applicable only to the extent that this will not cause unfair competition.

ê 2004/22/EC recital 7

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

ê 2004/22/EC recital 8 (adapted)

(9) The performance of measuring instruments is particularly sensitive to the environment, Ö in Õ particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference Ö should Õ forms an integral part of this Directive and the immunity requirements of Council Directive 89/336/EEC 2004/108/EC of the European Parliament and of the Council of 3 May 1989 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC[13] should therefore not apply.

ê 2004/22/EC recital 17 (adapted)

ð new

(10) ð In order to ensure the free circulation of measuring instruments in the Union, ï Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the ‘CE’ Ö CE Õ marking and supplementary metrology marking in accordance with the provisions of this Directive.

ê 22/2004 recital 18 (adapted)

(11) 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 Ö Union-wide Õ effect of this objective.

ò new

(12) Economic operators should be responsible for the compliance of measuring instruments, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety and the protection of users, and to guarantee fair competition on the Union market.

(13) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market measuring instruments which are in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution process.

(14) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. Conformity assessment should therefore remain the obligation of the manufacturer alone.

(15) It is necessary to ensure that measuring instruments from third countries entering the Union market comply with the requirements of this Directive, and in particular that the appropriate assessment procedures have been carried out by manufacturers with regard to those measuring instruments. Provision should therefore be made for importers to make sure that the measuring instruments they place on the market comply with the requirements of this Directive and that they do not place on the market measuring instruments which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers are available for inspection by the supervisory authorities.

(16) The distributor makes a measuring instrument available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of the measuring instrument does not adversely affect the compliance of the measuring instrument.

(17) When placing a measuring instrument on the market, every importer should indicate on the measuring instrument his name and the address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the product does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the product.

(18) Any economic operator that either places a measuring instrument on the market under its own name or trademark or modifies a measuring instrument in such a way that compliance with the requirements of this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(19) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the measuring instrument concerned.

(20) Ensuring traceability of a measuring instrument throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non compliant measuring instruments available on the market.

ê 2004/22/EC recital 9 (adapted)

ð new

(21) Community legislation should specify Ö This Directive should be limited to the expression of Õ 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. ð In order to facilitate conformity assessment with those requirements it is necessary to provide for presumption of conformity for measuring instruments which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No […/…] of the European Parliament and of the Council of […] on European Standardisation and amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament and of the Council[14] for the purpose of expressing detailed technical specifications of those requirements. ï

ò new

(22) Regulation (EU) No […/…] [on European Standardisation] provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy requirements of this Directive.

ê 2004/22/EC recital 12 (adapted)

(23) 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 Ö should be allowed as Õ an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity.

ê 2004/22/EC recital 13

(24) 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.

ò new

(25) In order to enable economic operators to demonstrate and the competent authorities to ensure that measuring instruments made available on the market comply with the essential requirements it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. However, it is necessary to adapt those modules in order to reflect specific aspects of metrological control.

ê 2004/22/EC recital 14 (adapted)

(26) The conformity assessment of sub-assemblies should Ö be carried out in accordance with Õ 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.

ê 2004/22/EC recital 15

(27) 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[15]. 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.

ò new

(28) Manufacturers should draw up an EU declaration of conformity to provide detailed information on the conformity of a measuring instrument with the requirements of this Directive and of other relevant Union harmonisation legislation.

(29) The CE marking and the supplementary metrology marking, indicating the conformity of a measuring instrument, are the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking and the supplementary metrology marking should be laid down in this Directive.

ê 2004/22/EC recital 10 (adapted)

ð new

(30) In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, Ö it is necessary to establish Õ essential requirements may give rise to the establishment of environmental or accuracy classes ð as essential requirements ï .

ê 2004/22/EC recital 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.

ò new

(31) The conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

ê 2004/22/EC recital 16 (adapted)

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[16].

ò new

(32) Experience has shown that the criteria set out in Directive 2004/22/EC that conformity assessment bodies have to fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services. Those requirements should take into account continued development in measurement technology.

(33) In order to ensure a consistent level of quality in the performance of conformity assessment of measuring instruments, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

(34) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Directive.

(35) The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

(36) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

(37) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the measuring instruments to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

(38) It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

(39) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

ê 22/2004 recital 17 (adapted)

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.

ê 22/2004 recital 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.

ò new

(40) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

(41) In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to measuring instruments.

(42) Directive 2004/22/EC already provides for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against measuring instruments it considers to be non-compliant. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard clause procedure, with the view to making it more efficient and drawing on expertise available in Member States.

(43) The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to measuring instruments presenting a risk to the aspects of public interest protection covered by this Directive. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such measuring instruments.

(44) Where Member States and the Commission agree as to the justification for a safeguard measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.

ê 2004/22/EC recital 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.

ê 2004/22/EC recital 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.

ê 2004/22/EC recital 21

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

ê 2004/22/EC recital 22 (adapted)

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[17].

ê 2004/22/EC recital 23

The activity of the Measuring Instruments Committee should include proper consultations with representatives of interested parties.

ê 2004/22/EC recital 24 (adapted)

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,

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(46) It is necessary to provide for transitional arrangements that allow making available on the market and putting into use measuring instruments that have already been placed on the market in accordance with Directive 2004/22/EC.

(47) The Member States should lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

(48) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred to the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers[18].

(49) The examination procedure should be used for the implementing decisions with respect to the objections to the internationally agreed normative documents whose references were already published in the Official Journal of the European Union and which the Commission considers justified, given that such decisions could have consequences on the presumption of conformity with the applicable essential requirements.

(50) In order to take into account the developments in the measurement technology, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amendments to the instrument-specific Annexes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(51) The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

(52) Since the objective of this Directive, namely to ensure that measuring instruments on the market fulfil the requirements providing a high level of protection of the public interests covered by this Directive while guaranteeing the functioning of the internal market cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(53) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with earlier Directives. The obligation to transpose the provisions which are unchanged arises under earlier Directives.

(54) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in Annex XIII, Part B,

ê 2004/22/EC (adapted)

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HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

Ö GENERAL PROVISIONS Õ

Article 31

Object Ö Subject matter Õ

This Directive establishes the requirements that the devices and systems referred to in Article 1 Ö measuring instruments Õ have to satisfy with a view to their being placed ð made available ï on the market and/or put into use for those Ö the measuring Õ tasks mentioned Ö referred to Õ in Article 23(1).

Article 12

Scope

1. This Directive applies to the Ö measuring instruments Õ devices and systems with a measuring function defined in the instrument-specific aAnnexes III to XII Ö , hereinafter instrument-specific Annexes, Õ 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).

ê 2004/22/EC

2. This Directive is a specific Directive in respect of requirements for electromagnetic immunity in the sense of Article 21(24) of Directive 2004/108/EC 89/336/EEC. Directive 2004/108/EC 89/336/EEC continues to apply with regard to emission requirements.

ê 2004/22/EC (adapted)

Article 23

Ö Optionality Õ

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.

ê 2004/22/EC

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

ê 2004/22/EC (adapted)

Article 4

Definitions

For the purposes of this Directive Ö the following definitions apply Õ :

ê 2004/22/EC

(a1) ‘measuring instrument’ means any device or system with a measurement function that is covered by Articles 1 and 32(1);

(b2) ‘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;

(c3) ‘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;

ê 2004/22/EC (adapted)

(i4) ‘normative document’ means a document containing technical specifications adopted by the Ö International Õ Organisation Ö of Legal Metrology, hereinafter “OIML” Õ Internationale de Métrologie Légale (OIML), subject to the procedure stipulated in Article 16(1).

(e5) ‘placing on the market’ means Ö the first Õ making available for the first time Ö of a measuring instrument on Õ in the Community Ö Union market Õ an instrument intended for an end user, whether for reward or free of charge;

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(6) ‘making available on the market‘ means any supply of a measuring instrument for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

ê 2004/22/EC

(f7) ‘putting into use’ means the first use of an instrument intended for the end user for the purposes for which it was intended;

ê 2004/22/EC (adapted)

ð new

(d8) ‘manufacturer’ means a Ö any Õ natural or legal person responsible for the conformity of the ð who manufactures a measuring instrument or has a ï measuring instrument ð designed or manufactured, and ï with this Directive with a view to either placing it on the market ð markets that measuring instrument ï under his own name ð or trademark ï and/or putting Ö puts Õ it into use for his own purposes;

ê 2004/22/EC (adapted)

(g9) ‘authorised representative’ means a Ö any Õ natural or legal person who is established within the Community Ö Union Õ and authorised by Ö who has received a written mandate from Õ a manufacturer, in writing, to act on his behalf for Ö in relation to Õ specified tasks within the meaning of this Directive;

ò new

(10) ‘importer’ means any natural or legal person established within the Union who places a measuring instrument from a third country on the Union market;

(11) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a measuring instrument available on the market;

(12) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(13) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a measuring instrument;

ê 2004/22/EC

ð new

(h14) ‘harmonised standard’ means ð harmonised standard as defined in Article 2(1)(c) of Regulation (EU) No […/…] [on European Standardisation] ï 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[19] and prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations ;

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(15) ‘accreditation’ means accreditation as defined in Article 2(10) of Regulation (EC) no 765/2008;

(16) ‘national accreditation body’ means national accreditation body as defined in Article 2(11) of Regulation (EC) no 765/2008;

(17) "conformity assessment" means the process demonstrating whether the requirements of this Directive relating to a measuring instrument have been fulfilled;

(18) "conformity assessment body" means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(19) "recall" means any measure aimed at achieving the return of a measuring instrument that has already been made available to the end user;

(20) "withdrawal" means any measure aimed at preventing a measuring instrument in the supply chain from being made available on the market;

(21) "CE marking" means a marking by which the manufacturer indicates that the measuring instrument is in conformity with the applicable requirements set out in the Union harmonisation legislation providing for its affixing;

(22) "Union harmonisation legislation" means any Union legislation harmonising the conditions for the marketing of products.

ê 2004/22/EC

Article 5

Applicability to sub-assemblies

ê 2004/22/EC (adapted)

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.

ê 2004/22/EC

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

ê 2004/22/EC (adapted)

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

ê 2004/22/EC

ð new

Member States may require, if it is needed for correct use of the instrument, the information referred to in point 9 of Annex I or in the relevant instrument-specific aAnnexes to be provided in the official language(s) of the Member State in which the instrument is placed ð made available ï on the market.

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

ê 2004/22/EC (adapted)

Article 87

Placing Ö Making available Õ on the market and putting into use

ê 2004/22/EC (adapted)

ð new

1. Member States shall not impede for reasons covered by this Directive the placing ð making available ï on the market and/or putting into use of any measuring instrument that carries the ‘CE’ Ö CE Õ marking and supplementary metrology marking in accordance with Article 723.

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

ê 2004/22/EC (adapted)

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.

ê 2004/22/EC

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

(a) the instrument-specific aAnnexes 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.

ê 2004/22/EC (adapted)

ð new

In either case falling under Ö For the purposes of point Õ (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. Ö or similar events Õ , Member States shall not prevent the showing of Ö measuring Õ instruments not in conformity with this Directive, provided that a visible sign clearly indicates their non-conformity and their non-availability for placing ð making available ï on the market and/or putting into use until Ö they are Õ brought into conformity.

ò new

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 8 [Article R2 of Decision No 768/2008/EC]

Obligations of manufacturers

1. When placing their measuring instruments on the market and/or putting them into use, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument specific Annexes.

2. Manufacturers shall draw up the required technical documentation referred to in Article 19 and carry out the relevant conformity assessment procedure referred to in Article 18 or have it carried out.

Where compliance of a measuring instrument with the applicable requirements of this Directive has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking and the supplementary metrology marking.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the measuring instrument has been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in measuring instrument design or characteristics and changes in the harmonised standards, normative documents or in technical specifications by reference to which conformity of a measuring instrument is declared shall be adequately taken into account.

When deemed appropriate with regard to the performance of a measuring instrument, manufacturers shall carry out sample testing of measuring instruments made available on the market, investigate and, if necessary, keep a register of complaints, of non-conforming measuring instruments and measuring instrument recalls, and shall keep distributors informed of any such monitoring.

5. Manufacturers shall ensure that their measuring instruments bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the measuring instrument does not allow it, that the required information is provided on the packaging or in a document accompanying the measuring instrument.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the measuring instrument or, where that is not possible, on its packaging or in a document accompanying the measuring instrument. The address must indicate a single point at which the manufacturer can be contacted.

7. Manufacturers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end‑users, as determined by the Member State concerned.

8. Manufacturers who consider or have reason to believe that a measuring instrument which they have placed on the market is not in conformity with this Directive shall immediately take the necessary corrective measures to bring that measuring instrument into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the measuring instrument presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the measuring instrument available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the measuring instrument, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by measuring instruments which they have placed on the market.

Article 9 [Article R3 of Decision No 768/2008/EC]

Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 8(1) and the drawing up of technical documentation shall not form part of the authorised representative's mandate.

2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 10 years after the measuring instrument has been placed on the market;

(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a measuring instrument;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by measuring instruments covered by their mandate.

Article 10 [Article R4 of Decision No 768/2008/EC]

Obligations of importers

1. Importers shall place only compliant measuring instruments on the Union market.

2. Before placing a measuring instrument on the market and/or putting a measuring instrument into use importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the measuring instrument bears the CE marking and the supplementary metrology marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 8(5) and (6).

Where an importer considers or has reason to believe that a measuring instrument is not in conformity with the essential requirements set out in Annex I and in the relevant instrument specific Annexes, he shall not place the measuring instrument on the market until it has been brought into conformity. Furthermore, where the measuring instrument presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the measuring instrument or, where that is not possible, on its packaging or in a document accompanying the measuring instrument in accordance with point 9.2 of Annex I.

4. Importers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end-users, as determined by the Member State concerned.

5. Importers shall ensure that, while a measuring instrument is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in Annex I and in the relevant instrument specific Annexes.

6. When deemed appropriate with regard to the performance of a measuring instrument, importers shall carry out sample testing of marketed measuring instruments, investigate, and, if necessary, keep a register of complaints, of non-conforming measuring instruments and measuring instrument recalls, and shall keep distributors informed of such monitoring.

7. Importers who consider or have reason to believe that a measuring instrument which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that measuring instrument into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the measuring instrument presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the measuring instrument available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

8. Importers shall, for 10 years after the measuring instrument has been placed on the market keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a measuring instrument in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by measuring instruments which they have placed on the market.

Article 11 [Article R5 of Decision No 768/2008/EC]

Obligations of distributors

1. When making a measuring instrument available on the market and/or put into use, distributors shall act with due care in relation to the requirements of this Directive.

2. Before making a measuring instrument available on the market and/or putting a measuring instrument into use distributors shall verify that the measuring instrument bears the CE marking and the supplementary metrology marking, that it is accompanied by the required documents and by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end-users in the Member State in which the measuring instrument is to be made available on the market and/or put into use, and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3).

Where a distributor considers or has reason to believe that a measuring instrument is not in conformity with the essential requirements set out in Annex I and in the relevant instrument specific Annexes, he shall not make the measuring instrument available on the market or put it into use, until it has been brought into conformity. Furthermore, where the measuring instrument presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

3. Distributors shall ensure that, while a measuring instrument is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Annex I and in the relevant instrument specific Annexes.

4. Distributors who consider or have reason to believe that a measuring instrument which they have made available on the market or put into use is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that measuring instrument into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the measuring instrument presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the measuring instrument available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

5. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a measuring instrument. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by measuring instruments which they have made available on the market.

Article 12 [Article R6 of Decision No 768/2008/EC]

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 8, where he places a measuring instrument on the market under his name or trademark or modifies a measuring instrument placed on the market in such a way that compliance with the requirements of this Directive may be affected.

Article 13 [Article R7 of Decision No 768/2008/EC]

Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities, for 10 years:

(a) any economic operator who has supplied them with a measuring instrument;

(b) any economic operator to whom they have supplied a measuring instrument.

Economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the measuring instrument and for a period of 10 years after they have supplied the measuring instrument.

ê 2004/22/EC (adapted)

CHAPTER 3

Ö CONFORMITY OF MEASURING INSTRUMENTS Õ

Article 1314 [Article R8 of Decision 768/2008/EC]

Harmonised standards and normative documents Ö Presumption of conformity Õ

ê 2004/22/EC

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.

ò new

1. Measuring instruments which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements covered by those standards or parts thereof, set out in Annex I and in the relevant instrument specific Annexes.

2. Measuring instruments which are in conformity with the normative documents or parts there of, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those normative documents or parts thereof, set out in Annex I and in the relevant instrument specific Annexes.

ê 2004/22/EC (adapted)

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) III to XII. 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.

ê 2004/22/EC

4. Member States shall presume compliance with the appropriate tests mentioned in point (i) of Article 1019(3) if the corresponding test programme has been performed in accordance with the relevant documents mentioned in paragraphs 1 to, 2 and 3 and if the test results ensure compliance with the essential requirements.

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[Article 15]

[Where a harmonised standard satisfies the requirements which it covers and which are set out in Annex I and in the relevant instrument specific Annexes or Article 28, the Commission shall publish the reference of that standard in the Official Journal of the European Union].

ê 2004/22/EC (adapted)

ð new

Article 16

Functions of the Measuring Instruments Committee Ö Publication of the references of normative documents Õ

1. ð Where a normative document satisfies the requirements which it covers and which are set out in Annex I and in the relevant instrument specific Annexes, the Commission may ï , 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 reference of the Ö that Õ normative documents and the list referred to in point (a) in the Official Journal of the European Union, C series.

ê 2004/22/EC (adapted)

Article 17

Ö Withdrawal of the references of normative documents Õ

3. Where Ö When Õ a Member State or the Commission considers that a normative document whose references have Ö has Õ been published in the Official Journal of the European Union, C series, in accordance with paragraph 1(b), does not fully meet Ö entirely satisfy Õ the essential requirements Ö which it covers and which are set out Õ referred to in Annex I and in the relevant instrument-specific Annexes, that Member State or the Commission shall Ö decide Õ 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 Ö of Õ the Ö that Õ normative document concerned from publication in the Official Journal of the European Union.

ò new

Those decisions shall be adopted in accordance with the examination procedure referred to in Article 46(2).

ê 2004/22/EC (adapted)

Article 918

Conformity assessment Ö procedures Õ

ê 2004/22/EC

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 aAnnex. The manufacturer shall provide, where appropriate, technical documentation for specific instruments or groups of instruments as set out in Article 10.

ê 2004/22/EC (adapted)

The conformity assessment modules making up the procedures are described Ö set out Õ in Annexes A to H1 Annex II.

ê 2004/22/EC

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 1019

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.

ê 2004/22/EC (adapted)

2. The technical documentation shall be sufficiently detailed to ensure Ö compliance with the following requirements Õ :

ê 2004/22/EC

(a) the definition of the metrological characteristics,;

ê 2004/22/EC (adapted)

(b) the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and;

(c) the integrity of the instrument.

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

ê 2004/22/EC

(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 1314, 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 1314 have not been applied;

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

ê 2004/22/EC (adapted)

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

ê 2004/22/EC

– 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.

ê 2004/22/EC (adapted)

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

ê 2004/22/EC

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.

ê 2004/22/EC

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.

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 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).

ò new

Article 20 [Article R10 of Decision No 768/2008/EC]

EU declaration of conformity

1. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Annex I and in the relevant instrument specific Annexes has been demonstrated.

2. The EU declaration of conformity shall have the model structure set out in Annex III of Decision No 768/2008/EC, shall contain the elements specified in the relevant modules set out in Annex II to this Directive and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which market the measuring instrument is placed or made available.

3. Where a measuring instrument is subject to more than one Union acts requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up on respect of all such Union acts. That declaration shall contain the identification of the acts concerned, including the publication references.

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the measuring instrument.

ê 2004/22/EC (adapted)

Article 721

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’ Ö CE Õ marking and the supplementary metrology marking as specified in Article 1722.

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.

ê 2004/22/EC

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 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.

ê 2004/22/EC (adapted)

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.

ê 2004/22/EC

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.

ê 2004/22/EC (adapted)

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.

ê 2004/22/EC

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.

ò new

Article 22 [Article R11 of Decision No 768/2008/EC]

General principles of the CE marking and of the supplementary metrology marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

ê 2004/22/EC (adapted)

17.2. The supplementary metrology marking shall consist 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’ Ö CE Õ marking. The supplementary metrology marking shall immediately follow the ‘CE’ marking.

ò new

Article 23 [Article R12 of Decision No 768/2008/EC]

Rules and conditions for affixing the CE marking and the supplementary metrology marking

1. The CE marking and the supplementary metrology marking shall be affixed visibly, legibly and indelibly to the measuring instrument or to its data plate. Where that is not possible or not warranted on account of the nature of the measuring instrument, they shall be affixed to the packaging and to the accompanying documents, where the legislation concerned provides for such documents.

ê 2004/22/EC

4.2. 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.

ò new

3. The CE marking and the supplementary metrology marking shall be affixed before the measuring instrument is placed on the market.

ê 2004/22/EC (adapted)

2.4. The ‘CE’ Ö CE Õ 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.

5. The supplementary metrology marking shall immediately follow the ‘CE’ Ö CE Õ marking.

ò new

The CE marking and the supplementary metrology marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase.

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

6. The CE marking, the supplementary metrology marking and, where applicable, the identification number referred to in paragraph 5 may be followed by a pictogram or any other mark indicating a special risk or use.

The identification number of the notified body concerned shall be indelible or self destructive upon removal.

CHAPTER 4

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 24 [Article R13 of Decision No 768/2008/EC]

Notification

1. Member States shall notify the Commission and the other Member States of bodies authorised to carry out third‑party conformity assessment tasks under this Directive. That notification shall include information on the kind(s) of measuring instrument(s) for which each body has been designated and, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification.

ê 2004/22/EC (adapted)

2. If a Member State has not introduced national legislation for tasks mentioned under Ö referred to in Õ Article 23, it shall retain the right to designate and notify a body for tasks relating to that Ö the measuring Õ instrument Ö concerned Õ .

ò new

Article 25 [Article R14 of Decision No 768/2008/EC]

Notifying authorities

1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 30.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26(1) to (6). In addition it shall have arrangements to cover liabilities arising out of its activities.

4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Article 26 [Article R15 of Decision No 768/2008/EC]

Requirements relating to notifying authorities

1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality of the information it obtains.

6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 27 [Article R16 of Decision No 768/2008/EC]

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 28 [Article R17 of Decision No 768/2008/EC]

Requirements relating to notified bodies

1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under national law and have legal personality.

3. A conformity assessment body shall be a third‑party body independent of the organisation or the measuring instrument it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of measuring instruments which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the measuring instruments which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed measuring instruments that are necessary for the operations of the conformity assessment body or the use of such measuring instruments for personal purposes.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those measuring instruments, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

The second subparagraph does not, however, preclude the possibility of exchanges of technical information between the manufacturer and the body for the purposes of conformity assessment.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Article 24 and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of measuring instruments in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the measuring instrument technology in question and the mass or serial nature of the production process.

It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7. The personnel responsible for carrying out conformity assessment activities shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the essential requirements set out in Annex I and in the relevant instrument specific Annexes, of the applicable harmonised standards and normative documents and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8. The impartiality of the conformity assessment bodies, their top level management and of the assessment personnel shall be guaranteed.

The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Article 24 or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activit