Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on measuring instruments

(presented by the Commission)

TABLE OF CONTENTS

EXPLANATORY MEMORANDUM

1. BACKGROUND INFORMATION

1.1 Context

1.2 Market characteristics

1.3 The existing legislation

1.4 The need for replacement

1.5 The Measuring Instruments Directive

2. THE PROPOSAL

3. COHERENCE WITH COMMUNITY PRINCIPLES

3.1 Proportionality

3.2 Subsidiarity

4. COHERENCE WITH COMMUNITY POLICIES

4.1 Industrial policy

5. IMPACT ANALYSIS

5.1 The effects for the consumers

5.2 The effects for the manufacturers

5.3 Utilities sector

5.4 Sectors other than utilities

6. REFERENCE TO THE WORK PROGRAMME

7. RELEVANCE FOR THE EEA

8. EXTERNAL CONSULTATION

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on measuring instruments

CHAPTER I - SCOPE AND OBJECT

CHAPTER II - LEGAL METROLOGICAL CONTROL

CHAPTER III - ASSESSMENT OF CONFORMITY

CHAPTER IV - PRESUMPTION OF CONFORMITY

CHAPTER V - COMMITTEES

CHAPTER VI - MARKINGS

CHAPTER VII - GENERAL AND FINAL PROVISIONS

ANNEX I - Essential requirements

ANNEX II - Test programmes

ANNEX III - Criteria to be satisfied by bodies designated by the Member States for the carrying out of tasks pertaining to the conformity assessment modules

ANNEX IV - Technical documentation

ANNEX A - Declaration of conformity based on internal production control

ANNEX A1 - Declaration of conformity based on internal production control plus product testing by a notified body

ANNEX B - Type examination

ANNEX C - Declaration of conformity to type based on internal production control

ANNEX C1 - Declaration of conformity to type based on internal production control plus product testing by a notified body

ANNEX D - Declaration of conformity to type based on quality assurance

ANNEX D1 - Declaration of conformity based on quality assurance

ANNEX E - Declaration of conformity to type based on quality assurance

ANNEX E1 - Declaration of conformity based on quality assurance of final product inspection and testing

ANNEX F - Declaration of conformity to type based on product verification

ANNEX F1 - Declaration of conformity based on product verification

ANNEX G - Declaration of conformity based on unit verification

ANNEX H - Declaration of conformity based on full quality assurance

ANNEX H1 - Declaration of conformity based on full quality assurance plus design examination

Annex MI-001 - Water Meters

Annex MI-002 - Gas Meters

Annex MI-003 - Active electrical energy meters and measurement transformers

Annex MI-004 - Heat Meters

Annex MI-005 - Measuring Systems for the Continuous and Dynamic Measurement of Quantities of Liquids other than Water

Annex MI-006 - Automatic Weighing Instruments 100

CHAPTER I - Requirements common to one or more automatic weighing instruments 101

CHAPTER II - Automatic Catchweighers 102

CHAPTER III - Automatic gravimetric filling instruments 104

CHAPTER IV - Discontinuous totalizers 106

CHAPTER V - Continuous totalizers 107

CHAPTER VI - Automatic rail weighbridges 108

Annex MI-007 - Taximeters 109

Annex MI-008 - Material Measures 113

Chapter I - Material Measures of Length 113

Chapter II - Capacity Serving Measures 114

Annex MI-009 - Dimensional Measuring Instruments 116

CHAPTER I - Requirements common to all dimensional measuring instruments 117

Chapter II - Length Measuring Instruments 118

Chapter III - Area Measuring Instruments 119

CHAPTER IV - Multidimensional Measuring Instruments 120

Annex MI-010 - Evidential Breath Analysers 121

Annex MI-011 - Exhaust Gas Analysers 124

FINANCIAL STATEMENT 129

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs) 134

EXPLANATORY MEMORANDUM

1. BACKGROUND INFORMATION

1.1 Context

Together with legislation on mintage, legislation on measurements and measuring instruments is amongst the oldest in the world, reflecting the fact that the accuracy of measurement results affects the daily life of citizens in many ways, directly or indirectly. All developed countries have therefore metrological institutes that are charged with the task of establishing tracability of measurement results with the international metrological standards, maintained by the Bureau International des Poids et Mesures [1].

[1] The Bureau International des Poids et Mesures (BIPM) ensures worldwide unification of physical measurements. It does so by carrying out a number of tasks, one of which is establishing the fundamental standards and scales for measurement of the principal physical quantities and maintaining the international prototypes. The BIPM operates under the exclusive supervision of the Comité International des Poids et Mesures (CIPM), which itself comes under the authority of the Conférence Général des Poids et Mesures (CGPM), which is the highest authority in charge of the execution of the Convention du Mètre and consists of delegates from all the Member States of the Convention du Mètre. All EU Member States are member of the Convention du Mètre, except for Greece and Luxemburg.

Where measurement results are obtained by means of a measuring instrument, and where a minimum level of the measurement accuracy is required for reasons of public interest, this is achieved by subjecting the measuring instrument to legislative requirements that guarantee this minimum level of accuracy under normally foreseeable operating conditions. All Member States have such legislation in place long before the creation of the Community in 1957.

National legislation in respect of the measuring performance of measuring instruments is compatible with the principles of Article 30 of the EC Treaty, as its justification is public interest. Consequently, where such national legislations are incompatible with each other and lead to barriers to trade, the Internal Market for measuring instruments must be established by harmonisation of the national legislations.

The harmonisation commenced in 1971. The existing Community legislation is deficient in many ways, and the current proposal will replace the legislation in as far as necessary.

1.2 Market characteristics

Legal metrology's raison d'être is the protection of individual parties (mainly) in trading transactions, and ensuring the operation of the trading markets. It achieves its goal by establishing legal requirements for the instruments' accuracies and other performance characteristics.

Trading markets are wide ranging. Legal metrology deals therefore with measuring instruments as diverse as utility meters, retail shop weighing scales, belt weighers, filling installations for prepacked products, breath analysers, length measures and many others.

Hence, the market sector affected by legal metrology is extremely diverse and the manufacturers and users in this sector are as diverse as the measuring instruments themselves.

The measuring technology used in the design of measuring instruments has seen great changes over the last decades, notably the change from (electro-)mechanical to electronics and high tech digital micro-electronics. In parallel with this change in technology, a change in specialisation took place whereby manufacturers became more and more producers of key components and sub-assemblies of measuring instruments, or assemblers of measuring instruments.

The changes in technology and specialisation have also led to a greater concentration in the sector. More and more, general purpose measuring instruments and key components are manufactured by big, often multinational companies, whereas the small and medium sized companies are active in niche markets for specialised applications.

In spite of these changes in the market place the manufacturing base is still extremely diverse.

1.3 The existing legislation

The legislation on measuring instruments consists of a framework Directive 71/316/EEC plus 23 specific Directives (16 base Directives plus 7 amending Directives). Of these, 17 Directives (11 base Directives plus 6 amending Directives) will be repealed and replaced by the proposed Directive, hereafter also called the Measuring Instruments Directive.

More Directives may be repealed and brought under the field of application of the Measuring Instruments Directive at a later stage.

1.4 The need for replacement

The need for replacement of most of the acquis is a direct consequence of its Old Approach nature and optional character.

The specific Directives are product Directives, containing detailed technical specifications that are too restrictive in today's situation of rapidly changing measurement technologies. Continuous updating of the specifications has proven to be impractical, which explains why the technical contents of some of the Directives have become largely out of date and why no Directives exist for the newer kinds of measuring instrument that are subject to legal control today.

The conformity assessment procedures prescribed in the acquis are generally too restrictive as well, and none of today's modern procedures are offered to the manufacturer. In particular, no possibility exists for the use of an approved and supervised Quality System as an alternative to third party verification of the final products.

Finally, the optional character of the Directives in the acquis has led to parallel national legislation for all of the instruments that are inadequately covered by the acquis. These are in particular all the electronic instruments, which nowadays are the majority of all instruments.

1.5 The Measuring Instruments Directive

The proposed Measuring Instruments Directive intends to remedy many of the shortcomings described above.

It will be a New Approach Directive, aimed at creating an Internal Market for measuring instruments that are subject to legal metrological control, by

-establishing essential requirements and conformity assessment requirements while maintaining the high level of consumer protection existing already, and

-establishing mutual recognition among the Member States of the results of conformity assessment.

The essential requirements will be performance requirements, rather than design specifications. As such they will be largely insensitive to the evolution of technology, thus significantly reducing the need for future adaptation to technical progress.

The conformity assessment procedures are the modern procedures taken from the Global Approach to testing and certification. They reinforce the role and responsibility of the manufacturer in conformity assessment and have assimilated quality assurance principles.

The Measuring Instruments Directive will also be a Directive of total character, by which is meant that no parallel national regimes of legal control of measuring instruments may exist in the Member States after its entry into force.

The Measuring Instruments Directive has as legal basis Article 95 of the EC Treaty. It will be adopted by Parliament and Council jointly, after consultation of the Economic and Social Committee.

2. THE PROPOSAL

2.1 Many kinds of measuring instrument can be used for a variety of measurement tasks. Not all of these require that the measuring instrument be legally controlled for reasons of public interest.

At the basis of the legislations of the Member States in respect of measuring instruments lies therefore the principle that it is the measurement task for which it is being used that determines whether a measuring instrument is to be subject to legal metrological requirements or not. This is also the principle adopted in this proposal.

2.2 The decisions to prescribe the use of legally controlled measuring instruments for particular measurement tasks are decisions in respect of the level of protection that a Member State wishes to establish for its citizens. Some Member States may have good reasons to prescribe the use of legally controlled measuring instruments for a particular measurement task where other Member States do not, and vice-versa. The measurement tasks that require the use of legally controlled measuring instruments are therefore left unharmonised by this proposal and may hence differ from one Member State to another.

When for certain kinds of measuring instrument two community markets are being created by this approach, one for legally controlled instruments and another for non-controlled instruments, the decision to design and manufacture instruments for one or the other market is the manufacturer's commercial decision.

2.3 Where a Member State decides to prescribe the use of a legally controlled measuring instrument for a particular measurement task, the provisions of this Directive in respect of legally controlled measuring instruments apply without restriction. Alternatively, the Member State may decide not to prescribe the use of a legally controlled measuring instrument for the measurement task concerned, in which case no legal metrological requirements may apply that would present a technical barrier to trade.

2.4 The provisions of the Directive in respect of legal metrological control are limited to the free movement of measuring instruments. The provisions apply therefore to the right of being used for the measurement tasks concerned (the putting into use), and all stages leading up to the putting into use, i.e. the placing on the market.

The Directive contains no provisions to harmonise the national systems of inspection and reverification of the measuring instruments during their period of use [2]. Like the decisions on prescription of the use of legally controlled measuring instruments referred to in item 2, these systems of inspection and reverification impact only on the level of protection that Member States wish to provide for their citizens, not on the internal market for the instruments.

[2] Several kinds of measuring instruments are prone to changes with time in their metrological performance, in particular their level of accuracy, even if used carefully and correctly. Member States have therefore established national systems of inspection of those kinds of instruments during their period of use.

2.5 Not all measuring instruments that may be subject to legal metrological control in the Member States are covered by this Directive. Only those that have community wide importance are covered.

Measuring instruments that are subject to legal metrological control in one or more Member States and that are not covered by the application field of this Directive are covered by the provisions of Articles 28-30 of the Treaty on proportionality and mutual recognition.

2.6 The Directive applies the principles of the New Approach to Standardisation and Technical Harmonisation. The metrological requirements that legally controlled measuring instruments shall satisfy are therefore restricted to the essentials, without pre-empting technical solutions or impeding technological progress by being too specific. The requirements are therefore expressed in the form of performance requirements.

2.7 The conformity of a measuring instrument with the metrological requirements shall be declared first of all by the presence on it of the CE conformity marking. The provisions in respect of the CE conformity marking apply the principles, laid down in Council Decision 93/465/EEC of 22 July 1993.

However, as explained earlier, whether a measuring instrument needs to be legally controlled or not depends upon the measurement task for which it is being used. A measuring instrument that is used for a measurement task for which no legally controlled instrument is prescribed does not need therefore to be certified, in which case it will not carry the CE marking under this Directive. However, even when not certified under this Directive a measuring instrument may carry the CE marking because one or more other Directives prescribing the CE marking apply to it. To make it clear to the field inspectors and reverification officers whether a measuring instrument carries a CE marking under this Directive or under another, the legally controlled status of a measuring instrument requires in addition to the CE marking the supplementary metrology marking referred to in Article 5 of the Directive.

2.8 The Directive applies also the principles of the Global Approach to Testing and Certification. Therefore, the basic conformity assessment procedure that is proposed for each kind of measuring instrument covered reinforces as much as acceptable the role of the manufacturer. This is done by requiring as little intervention by a certification body as acceptable, and by proposing a procedure based on the use of a quality system where intervention by a certification body is required at the level of production or final product control.

The certification bodies are designated by the Member States and notified to the other Member States and the Commission. The designation by the Member States is subject to the application of a set of minimum conditions that the certification bodies shall satisfy.

The conformity assessment procedures that apply for each kind of measuring instrument are in conformity with Decision 93/465/EEC on the modules for the various phases of conformity assessment.

2.9 Possible technical solutions that satisfy the metrological requirements shall be given by selected harmonised European standards and international documents with a normative character, whose elaboration shall be entrusted by the Commission to the competent European and international bodies and whose application by the manufacturers shall give presumption of conformity with the requirements. The voluntary character of these documents will not impede the use, for whatever reason (manufacturer's creativity, progress in technology, etc.) of technical solutions not described in them.

2.10 Some of the requirements that the measuring instruments have to satisfy are necessarily dependant upon the evolution in technology. This is explained by the fact that the requirements dealt with in this Directive are not safety requirements, but metrological requirements. The most prominent example of a requirement that depends upon the evolution of technology is the measuring accuracy that a kind of measuring instrument shall have as a minimum. The lists of conformity assessment procedures that are regarded adequate for the different kinds of measuring instrument are also dependant upon the evolution in measurement technology.

To deal with the need for adaptation to technical progress, the Directive provides for delegation of this power to the Commission, subject to the condition that the Commission seeks the advice of the advisory Measuring Instruments Committee.

2.11 The provisions for market surveillance contain a safeguard clause, dealing in the usual manner with cases of systematic non-compliance of all or part of a particular model of measuring instrument. The provisions for market surveillance include also provisions for those cases where the safeguard clause does not apply, i.e. where the non-compliance is not systematic, but incidental.

2.12 The specific Directives for the measuring instruments covered are repealed.

Transition arrangements are provided to enable the manufacturers to fully exploit the marketing rights they had under the national rules before the entry into force of the harmonised rules, during the remaining period of validity after the entry into force of the harmonised rules.

3. COHERENCE WITH COMMUNITY PRINCIPLES

Legal control of measuring instruments touches on two different areas of competence: Fair trading, consumer protection, public health and others on the one hand, and free movement of the measuring instruments (i.e. the Internal Market) on the other hand. Both areas overlap.

3.1 Proportionality

At the basis of the need for legal metrological control lie the objectives of fair trading, consumer protection etc. To satisfy these needs, Member States

-prescribe that for certain measurement tasks legally controlled measuring instruments must be used;

-require that those measuring instruments may only be placed on the market and put into use if they satisfy adequate performance requirements;

-subject the measuring instruments during their period of use to periodic inspections and reverifications.

Such national legislation is compatible with the provisions of Article 30 of the Treaty.

Discrepancies in the national legislations in respect of the second indent referred to above lead to barriers to trade and infringe on the free movement of products, which is the exclusive competence of the Commission. In order to meet the objective of free movement a set of essential requirements, together with a set of conformity assessment requirements needs to be established.

Given that the barriers to trade that need to be eliminated are national legislations compatible with Article 30 of the Treaty, a legal instrument is required. Of the various legal instruments of which the Commission disposes, the Directive is the appropriate one. A regulation cannot provide the degree of flexibility that the Member States need to implement the harmonised requirements, in particular those on conformity assessment. A regulation would also not be compatible with the needs of the Commission's industrial policy.

The proposal contains therefore a harmonisation Directive that provides the high level of consumer protection required by Article 95, paragraph 3 of the Treaty.

3.2 Subsidiarity

The consumer protection elements of the first and third indents referred to above are the competence of the Member States. In line with the principle of subsidiarity the Measuring Instruments Directive is strictly limited to the establishment of the set of essential requirements and conformity assessment procedures corresponding to the second indent and leaves the consumer protection elements of the first and third indents to be dealt with by the Member States. (See also chapter II, items 2 and 4).

4. COHERENCE WITH COMMUNITY POLICIES

4.1 Industrial policy

The Measuring Instruments Directive provides an internal market for legally controlled measuring instruments. As such, it is an element in the completion of the Internal Market for industrial products, which itself is an element of the Community's industrial policy.

The industrial policy's objective is to create an industrial environment in Europe which promotes/stimulates competitiveness. It endeavours to achieve this by a series of specific measures and programmes, each addressing specific elements of competitiveness. Creation of an internal market for industrial goods is one such measure.

The elements of competitiveness are product quality, manufacturing efficiency/productivity, product innovation and quick adaptation to structural changes in the industrial environment.

Technical regulations for measuring instruments are needed for the provision of equity in the market place (fair trading and consumer protection). Accepting their necessity therefore, the only route to an internal market is through harmonisation of the technical regulations.

Creating an internal market, although necessary is not sufficient. Care must be taken that the advantages of the internal market are not offset by negative effects on competitiveness that might result from the (harmonised) technical requirements. In other words, the establishment of the internal market may not take place at the expense of other elements of competitiveness. Wherever possible the harmonised set of technical requirements shall therefore contribute to the various elements of competitiveness, or as a minimum shall not constrain the manufacturers as they strive towards competitiveness.

The provisions of the Measuring Instruments Directive respect these principles. Quality of the measuring instruments is guaranteed by the essential requirements, which are such as to guarantee the high level of protection required by Article 95, paragraph 3 of the Treaty. At the same time, product innovation and adaptation to changes in the industrial environment are not constrained by the requirements, since the requirements are performance requirements that do not pre-empt technical solutions or impede technological progress. Manufacturing efficiency or productivity are not directly affected, however the conformity assessment by the manufacturer based on quality assurance enables products to be placed on the market quicker than would be the case with conformity assessment by a third party.

5. IMPACT ANALYSIS

The legal control of measuring instruments aims at the protection of the parties concerned by the results of measuring instruments, mainly in the case of trading operations (fair trading). The effect of the legal control goes in fact beyond simple and straightforward consumer protection: without legal metrological control, no operation of the market would be possible at all.

The value of the products traded by mass, volume or length is enormous. Estimates are of the order of magnitude of 10 % of GDP. Creating equity in the market place, where the market is of such a size, is an economic and social necessity.

However, the legal control referred to above already exists. The proposed Measuring Instruments Directive will replace the current legislation for all of the reasons explained before, while preserving the high level of existing protection. It will not create additional burdens for the manufacturers. The question is then what impact the changes in the legislation will have on consumers and manufacturers.

5.1 The effects for the consumers

Consumers will not notice any effect of the new legislation, since the same high level of consumer protection is guaranteed that exists already today.

5.2 The effects for the manufacturers

For the manufacturers, the impact is fundamentally an improvement of their operating environment:

-The essential requirements, plus mutual recognition of the conformity assessment result, eliminates the need for multiple conformity assessments;

-The essential requirements are performance requirements wherever possible, hence do not restrict innovation;

-The conformity assessment procedures reinforce the role and responsibility of the manufacturer and recognise quality assurance by the manufacturer; Furthermore, the manufacturers may have the choice of a number conformity assessment procedures.

However, the effects of this improvement in operating environment are intangible. Notwithstanding this an amount of information on future expected trends was gathered by way of questionnaires sent to the organisations involved in the consultation (list given in business impact memorandum).

5.3 Utilities sector

The utilities sector is well represented both as manufacturers and users. Groups exist for electricity, gas, water and heat meters. Manufacturing is characterised by the presence of a few multinationals or their subsidiaries accounting for about 50 % of the market supply. The rest of the market is supplied by several tens of SME's [3].

[3] It is not always evident in the classifications if small subsidiaries of multinationals are considered SMEs.

Both manufacturers and users of gas and water meters comment on the impact of deregulation of markets and increased competition as a driver for greater demand for instruments.

The domestic instrument side of the market - the area of greatest use for controlled instruments, is dominated in these sectors by mechanical or electromechanical technology. A replacement technology must provide the same reliability over a long lifetime at an economic advantage to that of the existing technologies. For certain instruments, electricity meters for example, UK manufacturers point to the demand for more sophisticated meters allowing greater flexibility for customers to change suppliers of electricity during a twenty four hour period. It is expected that such changes in the market will continue to drive the need for innovative solutions.

5.4 Sectors other than utilities

Other instrument sectors are represented at European level by a diversity of groups, most of whose membership are SME's. Of these, the weighing instrument manufacturers group CECIP, stated that they expect the implementation of the directive to increase market competition based on factors of quality, features and price. Ongoing restructuring of the sector will be faciliated by the market access opportunities created, which is expected to lead to a greater concentration of companies and be accompanied by a reduction in employment. The loss of employment will be offset by business opportunities for new dealerships/distributors in some Member States. Other instruments sectors were unable to comment on likely impact.

6. REFERENCE TO THE WORK PROGRAMME

The presentation of this proposal to Council and Parliament is included as item 96/254 in the Commission's Work Plan for 1998.

7. RELEVANCE FOR THE EEA

This proposal is relevant to the Agreement on the European Economic Area. The experts from the signatories to the EEA Agreement participated in all meetings of the Working Group of experts that have been held. The decision of the EEA Joint Committee to integrate the directive with the EEA agreement will be taken after the necessary consultation with the EFTA Secretariat.

8. EXTERNAL CONSULTATION

The Commission services have discussed the various draft versions of this proposal extensively in a series of meetings, to which all parties affected by this Directive were always invited. The meetings took the form of plenary meetings with all parties concerned, or of specialist meetings with smaller groups of experts.

The parties concerned are the Member States, the EEA members, the federations of manufacturers of measuring instruments, of users of measuring instruments, of consumer interests, and the standards making bodies.

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on measuring instruments

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission [4],

[4] OJ C [...], [...], p. [...].

Having regard to the opinion of the Economic and Social Committee [5],

[5] OJ C [...], [...], p. [...].

Acting in accordance with the procedure laid down in Article 251 of the Treaty [6],

[6] OJ C [...], [...], p. [...].

Whereas:

(1) A number of measuring instruments are covered by specific Directives, adopted on the basis of Directive 71/316/EEC on common provisions for both measuring instruments and methods of metrological control [7]. Specific directives that are technically outdated should be repealed and replaced by an independent directive, which is in the spirit of Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards [8]. Specific Directives that are not outdated should remain governed by Directive 71/316/EEC.

[7] OJ L 202, 6.9.1971, p. 1.

[8] OJ C 136, 4.6.1985, p. 1.

(2) Measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, affecting the daily life of citizens in many ways directly and indirectly, require the use of legally controlled measuring instruments.

(3) Legal metrological control should not lead to barriers to the free movement of measuring instruments, the provision concerned should be the same in all member states and proof of conformity accepted throughout the Community.

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

(5) The performance of measuring instruments is particularly sensitive to the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference forms an integral part of this Directive and the immunity requirements of Council Directive 89/336/EEC of 3 May 1989 on electromagnetic compatibility [9], as last amended by Directive 93/68/EEC [10], would therefore not apply.

[9] OJ L 139, 23.5.1989, p. 19.

[10] OJ L 220, 30.8.1993, p. 1.

(6) Community legislation should specify essential requirements that do not impede technical progress. The legal requirements should therefore preferably be performance requirements. Regulations to remove technical barriers to trade should follow the new approach provided for in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards.

(7) European technical standards should therefore be drawn up whose technical and performance specifications comply with the essential requirements laid down by this Directive. Conformity with the specifications of those standards would give rise to a presumption of conformity with the essential requirements laid down by this Directive. Standards harmonised at European level are drawn up by private bodies and must retain their non-mandatory status. For this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognised as being the bodies that are competent to adopt harmonized standards that follow the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984.

(8) The drawing up of harmonised standards by CEN and CENELEC is to be carried out 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 [11], as amended by Directive 98/48/EC [12]. In relation to standardisation, it is advisable for the Commission to be assisted by the Committee set up under Directive 98/34/EC. The Committee will, if necessary, consult technical experts.

[11] OJ L 204, 21.7.1998, p. 37.

[12] OJ L 217, 5.8.1998, p. 18.

(9) In certain specialised fields the technical and performance specifications of internationally agreed normative documents can also comply, in part or in full, with the product specifications laid down in legislation. In those cases the use of these internationally agreed normative documents can be an alternative to the use of European technical standards.

(10) 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 internationally agreed normative document. The use of European technical standards or internationally agreed normative documents should therefore be optional.

(11) 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 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 conformity marking, which are intended to be used in the technical harmonisation Directives [13].

[13] OJ L 220, 30.8.1993, p. 23.

(12) In accordance with Article 2 of the Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [14], measures necessary for the implementation of this Directive should be adopted by use of the advisory procedure provided for in Article 3 of that Decision.

[14] OJ L 184, 17.7.1999, p. 23.

(13) The Member States should actively survey their markets and take all appropriate measures to non-complying instruments from being placed on their markets or being used. Adequate co-operation among the market surveillance authorities of the Member States is therefore necessary to ensure a Community-wide effect of the market surveillance activities.

(14) Member States should take all appropriate measures to ensure that measuring instruments that carry the CE conformity marking and supplementary marking are correctly placed on the market. Manufacturers should be informed of the grounds on which negative decisions in respect of their products were taken, and the legal remedies available to them.

(15) This Directive should repeal the Community legislation in respect of the measuring instruments covered by the following Council Directives:

-71/318/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to gas meters [15], as last amended by Commission Directive 82/623/EEC [16];

[15] OJ L 202, 6.9.1971, p. 21.

[16] OJ L 252, 27.8.1982, p. 5.

-71/319/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to meters for liquids other than water [17];

[17] OJ L 202, 6.9.1971, p. 32.

-71/348/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to ancillary equipment for meters for liquids other than water [18], as last amended by the Act of Accession of Austria, Finland and Sweden;

[18] OJ L 239, 25.10.1971, p. 9.

-73/362/EEC of 19 November 1973 on the approximation of the laws of the Member States relating to material measures of length [19], as last amended by Commission Directive 85/146/EEC [20];

[19] OJ L 335, 5.12.1973, p. 56.

[20] OJ L 54, 23.2.1985, p. 29.

-75/33/EEC of 17 December 1974 on the approximation of the laws of the Member States relating to cold water meters [21];

[21] OJ L 14, 20.1.1975, p. 1.

-75/410/EEC of 24 June 1975 on the approximation of the laws of the Member States relating to continuous totalizing weighing machines [22];

[22] OJ L 183, 14.7.1975, p. 25.

-76/891/EEC of 4 November 1976 on the approximation of the laws of the Member States relating to electrical energy meters [23];

[23] OJ L 336, 4.12.1976, p. 30.

-77/95/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to taximeters [24];

[24] OJ L 26, 31.1.1977, p. 59.

-77/313/EEC of 5 April 1977 on the approximation of the laws of the Member States relating to measuring systems for liquids other than water [25] as amended by Commission Directive 82/625/EEC [26];

[25] OJ L 105, 28.4.1977, p. 18.

[26] OJ L 252, 27.8.1982, p. 10.

-78/1031/EEC of 5 December 1978 on the approximation of the laws of the Member States relating to automatic checkweighing and weight grading machines [27];

[27] OJ L 364, 27.12.1978, p. 1.

-79/830/EEC of 11 September 1979 on the approximation of the laws of the Member States relating to hot-water meters [28].

[28] OJ L 259, 15.10.1979, p. 1.

(16) Manufacturers should be offered the possibility to exercise the rights obtained before the entry into force of this Directive, during a reasonable period. Transitional arrangements are therefore necessary.

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I - SCOPE AND OBJECT

Article 1 Scope

This Directive applies to the devices and systems with a measuring function defined in the instrument specific annexes MI-001 to MI-011.

Article 2 Object

This Directive establishes the essential requirements that the devices and systems referred to in Article 1 have to satisfy if they are subject to legal metrological control in a Member State, and the conformity assessment that they have to undergo in those circumstances, with a view to their placing on the market and putting into use.

It is a specific Directive in respect of requirements for electromagnetic immunity in the sense of Article 2(2) of Directive 89/336/EEC.

CHAPTER II - LEGAL METROLOGICAL CONTROL

Article 3 Definitions

For the purposes of this Directive:

(a) 'measuring instrument' means any device or system with a measurement function that is covered by the scope and object of this Directive, as laid down in Articles 1 and 2;

(b) 'sub-assembly' means a hardware device that functions independently and together with other sub-assemblies with which it is compatible, makes up a measuring instrument;

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

(d) 'manufacturer' means the physical or legal person who

-carries out the technical design of a measuring instrument, or has it carried out on his behalf, and

-manufactures the measuring instrument, or has it manufactured on his behalf, and

-places it lawfully on the market under his own name,

or,

the physical or legal person who

-takes responsibility for the conformity of the measuring instrument to the appropriate requirements of this Directive, and

-has taken all necessary measures to bear those responsibilities, and

-places the measuring instrument lawfully on the market under his own name;

(e) 'placing on the market' means the first passing of the product from the stage of manufacture to the stage of distribution and/or use on the Community market;

(f) 'putting into use' means the first use of a product for the purposes for which it was intended;

(g) 'authorised representative' means the physical or legal person who is authorised by a manufacturer, in writing, to act on his behalf for specified tasks. An authorised representative must be established within the Community if he is to act under this Directive;

(h) 'harmonised standard' means a technical specification adopted by the European Committee for Standardization (CEN) or the European Committee for Electrotechnical Standardization (CENELEC) or jointly by both, at the request of the Commission pursuant to Directive 98/34/EC, and prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations;

(i) 'normative document' means a document containing normative elements drawn up by the Organisation Internationale de Métrologie Légale.

Article 4 Essential requirements and assessment of conformity

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

2. The conformity of a measuring instrument with the essential requirements shall be assessed in accordance with the provisions of Article 7.

3. Where a measuring instrument consists of a number of sub-assemblies and where specific annexes exist laying down the essential requirements for all of these sub-assemblies that together make up the measuring instrument, the provisions of this Directive shall apply mutatis mutandis to each of these sub-assemblies.

Article 5 Conformity marking

1. The conformity of a measuring instrument with all the obligations contained in this Directive shall be indicated by the presence on it of the CE conformity marking and the supplementary metrology marking as specified in Article 13.

2. The CE conformity marking and supplementary metrology marking shall be affixed by, or under the responsibility of the manufacturer.

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

Article 6 Placing on the market and putting into use

1. Without prejudice to the provisions of Articles 13 and 14, Member States shall not impede for reasons covered by this Directive the placing on the market and putting into use of any measuring instrument that carries the CE conformity marking and supplementary metrology marking in accordance with Article 5.

2. Member States shall ensure that the use of any measuring instrument that carries the CE conformity marking and supplementary metrology marking in accordance with Article 5 shall not be impeded by rules or conditions in respect of aspects covered by this Directive which are imposed by contracting entities in pursuit of the relevant activities, as referred to in Article 2 of Council Directive 93/38/EEC [29].

[29] OJ L 199, 9.8.1993, p. 84.

CHAPTER III - ASSESSMENT OF CONFORMITY

Article 7 Assessment of conformity

Assessment of conformity of a measuring instrument with its 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 specific annex concerning that instrument.

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

Article 8 Notification

1. Member States shall notify to the other Member States and the Commission the bodies which they have designated to carry out the tasks pertaining to the conformity assessment modules referred to in Article 7, together with the identification numbers given by the Commission according to paragraph 4, the kind(s) of measuring instrument for which each body has been designated and in addition, where relevant, the instrument 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 Annex III for the designation of such bodies.

3. A Member State that has notified a body shall withdraw such notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall forthwith inform the other Member States and the Commission of any such withdrawal of a notification.

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

CHAPTER IV - PRESUMPTION OF CONFORMITY

Article 9 Harmonised standards and normative documents

1. Member States shall presume conformity with the essential requirements referred to in Article 4 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 whose references have been published in the C series of the Official Journal of the European Communities.

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 standards with which the instrument complies.

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

2. Member States shall presume conformity with the essential requirements referred to in Article 4 in respect of a measuring instrument that complies with the normative document referred to in Article 11(2)(c), whose references have been published in the C series of the Official Journal of the European Communities.

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.

CHAPTER V - COMMITTEES

Article 10 Committee on standards and technical regulations

Where a Member State or the Commission considers that a European harmonised standard as referred to in Article 9(1) does not fully meet the essential requirements referred to in Article 4, the Member State or the Commission shall bring the matter before the Standing Committee set up under 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 of the national standards from the publication referred to in the third subparagraph of Article 9(1).

Article 11 Measuring Instruments Committee

1. The Commission shall be assisted by a Standing Committee, the Measuring Instruments Committee, composed of representatives of the Member States and chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in compliance with Article 7(3) and Article 8 thereof.

Article 12 Functions of the Measuring Instruments Committee

1. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 11(2), may take any appropriate measure to:

(a) amend instrument specific annexes in respect of:

-the maximum permissible errors and accuracy classes,

-the rated operating conditions,

-the critical change values,

-the list of conformity assessment procedures referred to in Article 7;

(b) amend the test programmes laid down in Annex II;

(c) request the Organisation Internationale de Métrologie Légale to draw up a normative document containing normative elements conformity with which provides presumption of conformity with the corresponding essential requirements of this Directive;

(d) publish the references of the normative document referred to in point (c) in the C series of the Official Journal of the European Communities.

2. Where a Member State or the Commission considers that a normative document whose references have been published in the C series of the Official Journal of the European Communities in accordance with paragraph 2(d), does not fully meet the essential requirements referred to in Article 4, that Member State or the Commission shall bring the matter before the Measuring Instruments Committee, giving its reasons for doing so.

The Commission, acting in accordance with the procedure referred to in Article 11(2), shall inform the Member States whether or not it is necessary to withdraw the references of the normative document concerned from the publication referred to in the third subparagraph of Article 9(2).

CHAPTER VI - MARKINGS

Article 13 Markings

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

2. The supplementary metrology marking referred to in Article 5 consists of the capital letter M and the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the CE conformity marking. The supplementary metrology marking shall immediately follow the CE conformity marking.

3. The identification number of the notified body concerned referred to in Article 8, if prescribed by the conformity assessment procedure, shall follow the CE conformity marking and supplementary metrology marking. The measuring instrument shall carry no identification number of a notified body where that is not prescribed by the conformity assessment procedure.

4. When a measuring instrument consists of a set of devices operating together, the markings shall be present on the instrument's main device.

When a measuring instrument is too small or too sensitive to carry the markings referred to in paragraph 1, the markings shall be carried by the packing in which the instrument is offered for sale or, if applicable, the container in which the instrument is supplied.

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

Article 14 Market surveillance

1. Member States shall take all appropriate measures to ensure that measuring instruments that carry the CE conformity marking and supplementary metrology marking according to Article 5 shall be placed on the market and put into use only if, when correctly installed and used in accordance with the manufacturer's instructions, they satisfy the essential requirements referred to in Article 4, and they have undergone conformity assessment in accordance with Article 7.

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

In particular, the competent authorities shall exchange information concerning the extent to which instruments they examine comply with the obligations of this Directive, and the results of such examinations.

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

Information exchanged shall be kept confidential.

3. If a Member State establishes that all or part of the measuring instruments of a particular model that bear the CE conformity marking and the supplementary metrology marking do not satisfy the conditions set out in paragraph 1, it shall take all appropriate measures to withdraw those instruments from the market, prohibit or restrict their further being placed on the market, or prohibit or restrict their further being used.

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

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

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

The competent Member State shall take appropriate action against whomsoever has affixed the markings and shall inform the Commission and the other Member States thereof.

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

If the non-compliance is attributed to shortcomings in the standards, the Commission shall, after having consulted the parties concerned, bring the matter as soon as possible before the Committee referred to in Article 10.

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

CHAPTER VII - GENERAL AND FINAL PROVISIONS

Article 15 Decisions entailing refusal or restriction

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

Article 16 Repeals

The following Directives are repealed as from [1 July 2002] without prejudice to Article 17:

-Directive 71/318/EEC;

-Directive 71/319/EEC;

-Directive 71/348/EEC;

-Directive 73/362/EEC;

-Directive 75/33/EEC;

-Directive 75/410/EEC;

-Directive 76/891/EEC;

-Directive 77/95/EEC;

-Directive 77/313/EEC;

-Directive 78/1031/EEC;

-Directive 79/830/EEC.

Article 17 Transitional provisions

By way of derogation from Article 18(2), Member States shall permit, for measurement tasks for which they have prescribed the use of a legally controlled measuring instrument, the placing on the market and putting into use of measuring instruments that satisfy the rules applicable before [1 July 2002] until the expiration of the validity of the type approval of those measuring instruments or, in case of a type approval of indefinite validity, for a period of ten years from [1 July 2002].

Article 18 Transposition

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [1 July 2002] at the latest. They shall forthwith inform the Commission thereof.

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

Article 19 Entry into force

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

Article 20 Addressees

This Directive is addressed to the Member States.

Done at Brussels, [...]

For the European Parliament For the Council

The President The President

ANNEX I Essential requirements

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

The requirements that shall be met by measuring instruments to provide these objectives are set out below and are completed, where appropriate, by specific instrument requirements in Annexes MI-001 to MI-011 that provide more detail on certain aspects of the general requirements.

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

Instruments are deemed to satisfy the relevant aspects of requirements if manufacturers can demonstrate that the corresponding test programme(s) of Annex II has/have been performed and gave appropriate results.

Definitions

Measurand

The measurand is the particular quantity subject to measurement.

Influence quantity

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

Rated Operating Conditions

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

Disturbance

A disturbance is an influence quantity not normally making up the working conditions of the instrument for which values and performance requirements are prescribed.

Critical change value

The critical change value is the value at which the change in the measurement result is considered undesirable. The value is expressed in the unit of measurement in which the measurement result itself is expressed.

Material Measure

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

Direct sales

A trading transaction is direct sales if:

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

-the parties in the transaction must accept the measurement result on the spot and;

-the change of ownership and the payment take place on the spot, or their obligation is established on the spot, as a result of the acceptance by the parties of the measurement result.

Requirements

1. Allowable Errors

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

Unless stated otherwise, maximum permissible error is expressed as a bilateral value of the deviation from the true measurement value.

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

1.3 The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, taking account of the requirements for operating conditions laid down in the appropriate specific instrument requirements.

1.3.1 Climatic and mechanical environments are differentiated into classes A to I as described below.

C Climatic environments

C1 This class applies to continuously temperature-controlled enclosed locations. Humidity is not controlled. Heating, cooling or humidification is used to maintain the required conditions, where necessary. Measuring instruments may be exposed to solar radiation, heat radiation, and to movements of ambient air due to drafts from the air-conditioning system or open windows; they are not subject to condensed water, precipitation, or ice formations. The conditions of this class may be found in continuously manned offices, certain workshops, and other rooms for special applications.

C2 This class applies to enclosed locations whose temperature and humidity are not controlled. Heating may be used to raise low temperatures, especially in case where there is a large difference between the conditions of this class and the open air conditions. Measuring instruments may be exposed to solar and heat radiation and drafts and may be subject to condensed water, water from sources other than rain and to ice formations. The conditions of this class may be found in some entrances and staircases of buildings, in garages, cellars certain workshops, factory buildings and industrial process plants, ordinary storage rooms for frost-resistant products, farm buildings etc.

C3 This class applies to open locations with average climatic conditions, thus excluding polar and desert environments.

M Mechanical environments

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

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

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

>TABLE POSITION>

Table 1

1.3.2 Electromagnetic environments are classified as E1 or E2;

E1 Residential, commercial and light industrial,

E2 Industrial

2. Reproducibility

The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements.

3. Repeatability

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

3.2 For an instrument subject to significant random errors the difference between the mean values of subsequent series of results shall be small when compared with the maximum permissible error.

4. Discrimination and Sensitivity

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

5. Durability

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

6. Reliability

A measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious or can be easily and simply checked using devices apart from the instrument itself.

7. Suitability

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

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

7.3 Where the measurand is the attribute of a product that is conditioned by the measuring instrument, the conditioning shall be carried out adequately, taking account of the maximum permissible error for the measurement.

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

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

8. Protection against corruption

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

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

8.3 Software that is critical for metrological characteristics shall be identified as such and shall be secured. Its identification shall be easily available. Evidence of an intervention shall be available for a reasonable period of time.

8.4 Measurement data and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

8.5 The displays of utility measuring instruments shall not be able to be reset during use.

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

9.1 A measuring instrument shall bear the following inscriptions:

-manufacturer's mark or name,

-information in respect of its accuracy,

plus, when applicable:

-pertinent data in respect of the conditions of use,

-identity marking,

-number of the type examination certificate.

9.2 An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its accompanying container and/or associated documentation suitably marked.

9.3. A measuring instrument shall be accompanied by information on its operation. Information should include where relevant:

-rated operating conditions;

-climatic, mechanical and electromagnetic environment classes;

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

-instruction for correct operation and any special conditions of use.

9.4 Instruments used for utility measurements or groups of instruments do not necessarily require individual instruction manuals.

9.5. Unless specified otherwise in a specific instrument annex the scale interval for a measured value shall be in the form 1x10n, 2x10n, or 5x10n, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

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

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

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

10. Indication of result

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

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

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

10.4 A measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended.

10.5 A measuring instrument intended for domestic utility measurement purposes from which the measurement data can be read either by a mobile data capture unit or remotely via a transmission link shall be fitted with a display accessible to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay.

11. Further processing of data to conclude the trading transaction

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

-the measuring instrument is for direct sales trading transactions and;

-the measurement is non-repeatable and;

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

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

12. Conformity evaluation

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

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ANNEX II Test programmes

Introduction

Appropriate results obtained having carried out the test programmes are deemed to satisfy the particular aspect of the product requirement under evaluation. In the case of a particular instrument, values attributed in the test programmes to severity levels or combinations of severity levels for the climatic and mechanical classes A-I may be changed by direct reference in the specific annex.

Test set-ups and test procedures shall be according to internationally agreed documents.

1. Test Programmes

Test programmes are separated according to operating conditions as follows:

Programme 1 Electromagnetic environment

Programme 2 Climatic environment

Programme 3 Mechanical environment

Programme 4 Power supply

A further test programme, programme 5 concerns durability.

1.1 Applicability of test programmes

An instrument or sub-assembly is subjected to test according to its rated operating conditions which shall be in accordance with the requirements of the specific instrument annex.

1.2.1 Climatic and mechanical classes

The climatic and mechanical classes, A-I, are as outlined in Table 1 of Annex I.

The appropriate severity levels for testing are as set out below.

>TABLE POSITION>

Table 1 - Severity levels

1.2.2 Electromagnetic Environmental Classes

Class E1 - Residential, commercial and light industry environment

Class E2 - Industrial environment

1.3 Basic rules concerning the determination of errors

Errors shall be determined under normal test conditions. When the effect of one influence quantity is being evaluated, all other factors are to be kept relatively constant, at a value close to normal.

1.4 Basic rules for testing

Each influence quantity is applied and its effect evaluated separately. Metrological test shall be carried out during or after the application of the influence quantity whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur.

2. Programme 1: Electromagnetic environment

The test programme as outlined in Tables 2, 3 and 4 apply to the instrument or sub-assembly according to the electromagnetic environment, E1 or E2, in which the instrument is intended to be used.

Where the instrument or sub-assembly is intended to be used in a permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field - amplitude modulated test shall be within maximum permissible error, in all other cases the critical change value and the permissible effect is that laid down in the specific instrument Annex.

>TABLE POSITION>

Table 2

>TABLE POSITION>

Table 3: Radio frequency - common mode

>TABLE POSITION>

Table 4: Surges

3. Programme 2: Climatic environment

To verify operation within maximum permissible error under the relevant climatic environment conditions

3.1 Static Temperature

Where practicable both dry heat and cold tests may be combined in a cycle.

3.1.1 Dry heat

To verify operation within maximum permissible error under conditions of high temperature.

>TABLE POSITION>

3.1.2 Cold

To verify performance within maximum permissible error under conditions of low temperature

>TABLE POSITION>

3.2 Ambient humidity

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

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

3.2.1 Damp heat, steady-state (non-condensing)

To verify operation within maximum permissible error under conditions of high humidity and constant temperature.

>TABLE POSITION>

3.2.2 Damp heat, cyclic (condensing)

To verify operation within maximum permissible error under conditions of high humidity when combined with cyclic temperature changes.

>TABLE POSITION>

4. Programme 3: Mechanical environment

To verify operation within maximum permissible error under the relevant mechanical environment conditions

4.1 Vibration

The random vibration test is appropriate for evaluation of conditions where the magnitude of the influence quantity is not stable. The test for sinusoidal vibration is appropraite for evaluation of conditions where the frequenc(y)(ies) and the level(s) of effective acceleration are known and stable, or when a relevant resonance frequency is known.

4.1.1 Random vibration

To verify operation within maximum permissible error under conditions of random vibration.

>TABLE POSITION>

4.1.2 Sinsuidol vibration

To verify operation within maximum permissible error under conditions of vibration of a consistent character.

>TABLE POSITION>

4.2 Mechanical shock

To verify operation within maximum permissible error under conditions of mechanical shock

>TABLE POSITION>

5. Programme 4: Power supply

To verify operation within maximum permissible error under normal power supply conditions.

>TABLE POSITION>

6. Programme 5: Durability

To assess the possible occurrence of defects over the expected lifetime of the instrument or sub-assembly.

6.1 Gas meters

6.1.1 Diaphragm meters

6.1.1.1 Test specification: 5 000 hours at Qmax

6.1.1.2 Allowable errors

During and after test at flow rates of Qmin, 2Qmin, 0.1Qmax, 0.4Qmax, 0.7Qmax and Qmax:

-the error of indication at each flow rate in the range Qt to Qmax shall not differ from the corresponding initial value by more the 2 % for that flow rate.

-the error of indication shall be within twice the maximum permissible error.

6.1.2 Rotary positive displacement and turbine meters

6.1.2.1 Test specification: 1 000 hours, total duration shall not last more than two months.

6.1.2.2 Allowable errors

After test at flow rates of Qmin, 0.05Qmax, 0.15Qmax, 0.25Qmax, 0.4Qmax, 0.7Qmax and Qmax:

-the error of indication at each test flow rate shall not differ from the corresponding initial value by more than one third of the maximum permissible error for that flow rate.

-the error of indication shall be within the maximum permissible error.

6.2 Water meters

6.2.1 Water meters shall be submitted to two consecutive series of tests.

-Q3 less than or equal to 16m3/h

-First series (Cyclic test): 100 000 discontinuous cycles during which the flow-rate may vary between zero and Q3. Each cycle shall include at least one period during which the flow-rate must be zero and at least one period during which the flow-rate must be Q3.

-Second series (Continuous test): continuous flow at Q4 during 100 hours.

-Q3 greater than 16 m3/h

-First series: Continuous flow at Q3 during 750 hours

-Second series: Continuous flow at Q4 during 200 hours.

6.2.2 Allowable errors

6.2.2.1 Variation on measurement error after each series of tests when compared to initial measurement error shall not exceed:

-3 % of the metered volume between Q1 included and Q2 excluded.

-1.5 % of the metered volume between Q2 included and Q4 included.

6.2.2.2 Measurement error on volume metered after each series of tests shall not exceed:

-+/- 6 % of the metered volume between Q1 included and Q2 excluded

-+/- 2.5 % of the metered volume between Q2 included and Q4 included for water meters intended to meter water with a temperature between 0.1°C and 30°C,

-+/- 3.5 % of the metered volume between Q2 included and Q4 included for water meters intended to meter water with a temperature between 30°C and 90°C.

6.2.3 Volume of water

The volume of water passed through each tested meter and due to the two series of tests as defined in 2.1 must be at least:

600 x Q3 (in m3) for Q3 < 16 m3/h

1 000 x Q3 (in m3) for Q3 > 16 m3/h.

6.2.4 Tested flow rates

Measurement errors on volume of water must de determined at reference conditions before and after each series of tests, for each tested meter and at least for the following flow rates:

Q1 - (Q1+ Q2)/2 - Q2 - 0.1Q3 - 0.3Q3 - 0.5Q3 - Q3 - Q4.

6.2.5 Test conditions

Tests shall be carried out with water of an appropriate temperature to test the meter for the temperature range for which it is intended. Water used in testing shall be clean water having no solid particles in suspension, a low agressivity and a low proportion of calcium carbonate.

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ANNEX III Criteria to be satisfied by bodies designated by the Member States for the carrying out of tasks pertaining to the conformity assessment modules

Set out below are the criteria that Member States shall apply for the designation of bodies according to Article 8, paragraph 1.

1. The body, its director and the staff involved in conformity assessment work shall not be the designer, manufacturer, supplier, installer or user of the measuring instruments that they inspect, nor the authorised representative of any of these persons. Also 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 criteria do not, however, preclude in any way the possibility of exchanges of technical information for purposes of conformity assessment, between the manufacturer and the body.

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

3. The conformity assessment tasks 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 connected with the establishment or verification of product performance or specifications, it shall first ensure that the subcontractor meets the provisions of this Directive, and in particular of this Annex. 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 national authorities.

4. The body shall be able to carry out all the tasks assigned to such bodies by the Annex for which it has been notified, whether these tasks are carried out by the body itself or on its behalf and under its responsibility. It shall dispose in particular of the necessary staff and possess the necessary facilities for carrying out the technical and administrative tasks entailed in assessment and verification in a proper manner. It shall also have access to the equipment necessary for the required verification.

5. The body shall have

-sound vocational training, covering all assessment and verification operations for which the body was designated;

-satisfactory knowledge of the rules in respect of the inspections which it carries out, and adequate experience of such inspections;

-the ability required to draw up the certificates, records and reports to demonstrate that the inspections were carried out.

6. The impartiality of the body must be guaranteed. Its remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.

7. The body must have taken out civil liability insurance, unless liability is assumed by the Member State under national legislation or the Member State carries out the inspections itself directly.

8. The body's staff are bound to observe professional secrecy with regard to all information obtained in the course of exercising their duties pursuant to this Directive or any provision of national law putting this Directive into effect, except vis-à-vis the competent administrative authorities of the Member State in which their activities are carried out.

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ANNEX IV Technical documentation

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

The documentation shall include in so far as relevant for assessment:

-a general description of the instrument;

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

-descriptions and explanations necessary for the understanding of the above, including the operation of the instrument;

-a list of the standards referred to in Article 9, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 9 have not been applied;

-results of design calculations, examinations, etc;

-test reports;

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

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ANNEX A Declaration of conformity based on internal production control

1. The declaration of conformity based on internal production control is the conformity assessment procedure whereby the manufacturer or his authorised representative fulfils the obligations laid down hereafter, and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

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

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

Manufacturing

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

Written declaration of conformity

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

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

A copy of the declaration shall also be sent to one of the bodies notified for type examination according to Article 8 who's responsibility it shall be to periodically make the list of declarations of conformity received available to all Member States.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

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

Where neither the manufacturer nor his authorised representative is established within the Community, the obligations mentioned above shall be the responsibility of the importer or any other person who places the instrument on the Community market.

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ANNEX A1 Declaration of conformity based on internal production control plus product testing by a notified body

1. The declaration of conformity based on internal production control plus product testing by a notified body is the conformity assessment procedure whereby the manufacturer or his authorised representative fulfils the obligations laid down hereafter, and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

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

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

Manufacturing

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

Product checks

5. A notified body chosen by the manufacturer shall carry out product checks at random intervals, or have them carried out. An adequate sample of the final products, taken by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant document(s) referred to in Article 9, or equivalent tests, shall be carried out to check the conformity of the instruments with the appropriate requirements of this Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform the notified body shall take appropriate measures.

Written declaration of conformity

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

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

A copy of the declaration shall also be sent to one of the bodies notified for type examination according to Article 8 whose responsibility it shall be to periodically make the list of declarations of conformity received available to all Member States.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

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

Where neither the manufacturer nor his authorised representative is established within the Community, the obligations mentioned above shall be the responsibility of the importer or any other person who places the instrument on the Community market.

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ANNEX B Type examination

1. Type examination is the part of a conformity assessment procedure whereby a notified body examines the technical design of a measuring instrument and ascertains and attests that the technical design meets the provisions of this Directive that apply to the measuring instrument.

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

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

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

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

3. The application for type examination shall be lodged by the manufacturer or his authorised representative established within the Community with a notified body of his choice.

The application shall include:

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

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

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

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

-the supporting evidence for the adequacy of the technical design of those parts of the measuring instrument for which no specimens are required. This supporting evidence shall mention any relevant documents that have been applied, in particular where the relevant documents referred to in Article 9 have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4. The notified body shall:

For the specimens:

4.1. examine the technical documentation, verify that the specimens have been manufactured in conformity with it and identify the elements which have been designed in accordance with the relevant provisions of the relevant documents referred to in Article 9, as well as the elements which have been designed without applying the relevant provisions of those documents;

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

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

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

For the other parts of the measuring instrument:

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

For the manufacturing process:

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

5. Where the technical design meets the provisions of this Directive that apply to the measuring instrument, the notified body shall issue an EC type examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the examination, conditions (if any) for its validity and the necessary data for identification of the instrument.

All relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

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

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

7. Each notified body shall periodically make available to all Member States the list of:

-EC type examination certificates issued;

-EC type examination certificates refused;

-additions and amendments relating to certificates already issued.

Each notified body shall inform all Member States immediately of the withdrawal of an EC type examination certificate. Each Member State shall make this information available to the bodies that it has notified.

8. The other notified bodies may receive a copy of the EC type examination certificates and/or their additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.

9. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC type examination certificate and its additions with the technical documentation for a period ending 10 years after the last measuring instrument has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the importer or any other person who places the measuring instrument on the Community market.

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ANNEX C Declaration of conformity to type based on internal production control

1. The declaration of conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer or his authorised representative fulfils the obligations laid down hereafter and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

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

Written declaration of conformity

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

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

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

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

Where neither the manufacturer nor his authorised representative is established within the Community, the obligations mentioned above shall be the responsibility of the importer or any other person who places the instrument on the Community market.

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ANNEX C1 Declaration of conformity to type based on internal production control plus product testing by a notified body

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

Manufacturing

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

Product checks

3. A notified body chosen by the manufacturer shall carry out product checks at random intervals, or have them carried out. An adequate sample of the final products, taken by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant document(s) referred to in Article 9, or equivalent tests, shall be carried out to check the conformity of the product with the type as described in the EC type examination certificate and the appropriate requirements of the Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform the notified body shall take appropriate measures.

Written declaration of conformity

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

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

A copy of t