Directive 2009/34/EC of the European Parliament and of the CouncilShow full title

CHAPTER I BASIC PRINCIPLES

Article 1

1. This Directive shall apply to:

(a) instruments as defined in paragraph 2;

(b) units of measurement, the harmonisation of methods of measurement and metrological control and, where appropriate, the means required for application of such methods;

(c) the prescription, methods of measurement, metrological control and marking of quantities of pre-packaged products.

2. For the purpose of this Directive, ‘instruments’ shall mean measuring instruments, components of measuring instruments, additional devices and measurement equipment.

3. No Member State may, on the basis of this Directive and the separate Directives relating to it, prevent, prohibit, or restrict the placing on the market and/or entry into service of an instrument or of a product described in paragraph 1 if that instrument or product bears EC marks and/or signs in accordance with the conditions laid down in this Directive and in the separate Directives relating to the instrument or product in question.

4. Member States shall attach the same value to EC pattern approval and initial verification as to the corresponding national measures.

5. The separate Directives concerning the matters referred to in paragraph 1 shall specify:

• in particular, the measurement procedures and characteristics of, and the technical requirements for, their design and functioning, as regards the instruments referred to in paragraph 1(a),

• the requirements concerning points (b) and (c) of paragraph 1.

6. The separate Directives may fix the date on which the existing national provisions are to be replaced by Community provisions.

CHAPTER II EC PATTERN APPROVAL

Article 2

1. Member States shall grant EC pattern approval in accordance with the provisions of this Directive and of the relevant separate Directives.

2. EC pattern approval of instruments shall constitute their admission to EC initial verification and, where the latter is not required, the authorisation to place them on the market and/or to put them into service. If the separate Directive(s) applicable to a category of instruments exempt(s) that category from EC pattern approval, the instruments in that category shall be admitted directly to EC initial verification.

3. If their inspection equipment so permits, Member States shall grant EC pattern approval for every instrument which satisfies the requirements laid down in this Directive and the separate Directives relating to the instrument in question.

4. An application for EC pattern approval may be made only by the manufacturer or his representative established within the Community. For one and the same instrument, application may be made in one Member State only.

5. A Member State which has granted EC pattern approval shall take the necessary steps to ensure that it is kept informed of any modification of, or addition to, the approved pattern. It shall inform the other Member States of such alterations.

Modifications of, or additions to, an approved pattern must receive additional EC pattern approval from the Member State which granted EC pattern approval, where such changes influence or might influence measurement results or the prescribed conditions for use of the instrument.

However, in the case of a modified pattern, a new EC pattern approval shall be granted instead of an addition to the original EC pattern approval certificate if the pattern is modified after the provisions of this Directive or of the relevant separate Directive have been amended or adapted in such a way that the modified pattern could be approved only pursuant to the new provisions.

Article 3

When EC pattern approval is granted for ancillary equipment, the approval shall specify:

(a)

the patterns of instrument to which this equipment may be attached or in which it may be incorporated;

(b)

the general conditions for the overall functioning of the instruments for which it is approved.

Article 4

When an instrument has successfully completed the EC pattern approval examination laid down in this Directive and in the separate Directives relating to that instrument, the Member State which carried out that examination shall draw up an EC pattern approval certificate.

That Member State shall forward that certificate to the applicant.

In the cases provided for in Article 11 of this Directive or in a separate Directive, the applicant must, and in all other cases may, affix or cause to be affixed on each instrument conforming to the approved pattern the EC approval sign shown in the certificate.

Article 5

1. EC pattern approval shall be valid for 10 years. It may be extended for successive periods of 10 years. The number of instruments which may be manufactured in accordance with the approved pattern shall not be limited.

EC pattern approvals granted on the basis of the provisions of this Directive and of a separate Directive may not be extended after the date of the entry into force of any amendment to, or adaptation of, those Community provisions, in cases where such EC pattern approvals could not have been granted on the basis of the new provisions.

When EC pattern approval is not extended, that approval shall nevertheless continue to apply to instruments already in service.

2. Where use is made of new techniques not provided for in a separate Directive, EC pattern approval with limited effect may be granted, after prior consultation of the other Member States.

It may include the following restrictions:

(a) a limit on the number of instruments which may be covered by the approval;

(b) an obligation to notify the competent authorities of the places of installation;

(c) restrictions on use;

(d) special restrictions concerning the technique used.

However, it may not be granted unless:

(a) the separate Directive for that category of instruments has come into force;

(b) no derogation has been made from the maximum permissible errors laid down in the separate Directives.

The period of validity of such approval shall not exceed two years. It may be extended by up to three years.

3. The Member State which has granted the limited EC pattern approval referred to in paragraph 2 shall apply for adjustment to technical progress of Annexes I and II to this Directive, where appropriate, and of the separate Directives, in accordance with the procedure referred to in Article 17(2), as soon as it considers that a new technique has proved to be satisfactory.

Article 6

When EC pattern approval is not required for a category of instruments which meets the requirements of a separate Directive, the manufacturer may, on his own responsibility, affix to the instruments in this category the special sign described in point 3.3 of Annex I.

Article 7

1. The Member State which has granted EC pattern approval may withdraw it:

(a) if instruments for which this approval was granted do not conform to the approved pattern or to the provisions of the relevant separate Directive;

(b) if the metrological requirements specified in the certificate of approval or the provisions of Article 5(2) are not met;

(c) if it ascertains that approval was granted in an improper manner.

2. The Member State which has granted EC pattern approval must withdraw it if the instruments constructed according to an approved pattern reveal in service a defect of a general nature which makes them unsuitable for their intended use.

3. If the Member State which granted an EC pattern approval is informed by another Member State of the occurrence of one of the cases covered by paragraphs 1 and 2, it shall also take the measures provided for in those paragraphs, after consulting with that other Member State.

4. The Member State which declares that the case referred to in paragraph 2 has arisen may forbid the placing on the market and putting into service of the instruments concerned until further notice.

It shall immediately inform the other Member States and the Commission, stating the reasons on which its decision is based.

The same procedure shall apply in the cases referred to in paragraph 1, with respect to instruments which have been exempted from EC initial verification, if the manufacturer, after due warning, does not bring the instruments into conformity with the approved pattern or with the requirements of the relevant separate Directive.

5. If the Member State which granted the EC pattern approval disputes that the case referred to in paragraph 2 of which it has been informed has arisen, or disputes that the measures taken pursuant to paragraph 4 are justified, the Member States concerned shall endeavour to settle the dispute.

The Commission shall be kept informed. It shall, where necessary, hold appropriate consultations with the aim of reaching a settlement.

CHAPTER III INITIAL VERIFICATION

Article 8

1. EC initial verification constitutes the examination of a new or reconditioned instrument and the confirmation of its conformity to the approved pattern and/or to the requirements of this Directive and the separate Directives relating to the instrument in question. It is certified by the EC initial verification mark.

2. EC initial verification of instruments may be carried out by a method other than unit checking in the cases specified in the separate Directives and in accordance with the procedures adopted.

3. If their equipment so permits, Member States shall carry out EC initial verification of instruments submitted as having the measurement characteristics and satisfying the technical construction and functioning requirements laid down by the separate Directives relating to that category of instruments.

4. In the case of instruments bearing the EC initial verification mark, the obligation imposed on Member States under Article 1(3) shall last until the end of the year following that in which the EC initial verification mark was affixed, unless separate Directives provide for a longer period.

Article 9

1. When an instrument is submitted for EC initial verification, the Member State carrying out the examination shall determine:

(a) whether the instrument belongs to a category exempt from EC pattern approval and, if so, whether it satisfies the technical construction and functioning requirements laid down by the separate Directives relating to that instrument;

(b) whether the instrument has received EC pattern approval and, if so, whether it conforms to the approved pattern, and to the separate Directives relating to that instrument, in force on the date of issue of that EC pattern approval.

2. The examination carried out in EC initial verification relates in particular, in accordance with the separate Directives, to:

(a) the metrological characteristics;

(b) the maximum permissible errors;

(c) the construction, in so far as this guarantees that the measurement characteristics are not likely to deteriorate to any great extent under normal conditions of use;

(d) the presence of prescribed inscriptions and stamp plates or provisions for EC initial verification marking.

Article 10

When an instrument has successfully undergone EC initial verification, in accordance with the requirements of this Directive and of the separate Directives, the EC partial or final verification marks described in Annex II, point 3 shall be affixed to that instrument under the responsibility of the Member State concerned in accordance with the rules laid down in that point.

Article 11

When EC initial verification is not required for a category of instruments which meet the requirements of a separate Directive, the manufacturer shall, on his own responsibility, affix to the instruments in that category the special symbol described in point 3.4 of Annex I.

CHAPTER IV PROVISIONS COMMON TO EC PATTERN APPROVAL AND EC INITIAL VERIFICATION

Article 12

Member States shall take all necessary measures to prevent the use on instruments of marks or inscriptions liable to be confused with the EC signs or marks.

Article 13

Each Member State shall notify the other Member States and the Commission of the services, agencies and institutes which are duly authorised to carry out the examinations provided for in this Directive and in the separate Directives, to issue the EC pattern approval certificates and to affix the EC initial verification marks.

Article 14

Member States may require that the prescribed inscriptions be drawn up in their official language or languages.

CHAPTER V CONTROL OF INSTRUMENTS IN SERVICE

Article 15

The separate Directives shall specify the control requirements for instruments in service which bear EC signs or marks and in particular the maximum errors permitted in service. If national provisions in respect of instruments which do not bear EC signs or marks lay down less stringent requirements, the latter may serve as criteria for the controls.

CHAPTER VI ADJUSTMENT OF DIRECTIVES TO TECHNICAL PROGRESS

Article 16

The amendments necessary for adjusting to technical progress Annexes I and II to this Directive and the annexes to the separate Directives referred to in Article 1 shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive and the separate Directives, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(2).

However, this procedure shall apply neither to the chapter relating to imperial units of measurement of the annex to the Directive on units of measurement nor to the annexes, concerning quantity ranges for pre-packed quantities of products, to the Directives on pre-packed products.

Article 17

1. The Commission shall be assisted by the Committee for Adjustment to Technical Progress of the Directives referred to in Article 16.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

CHAPTER VII FINAL PROVISIONS

Article 18

All decisions taken pursuant to the provisions adopted in implementation of this Directive and of the separate Directives on the instruments in question and refusing to grant or extend EC pattern approval, withdrawing such approval, refusing to carry out EC initial verification or prohibiting placing on the market or entry into service shall state the reasons on which they are based. Such refusal, withdrawal or prohibition shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies.

Article 19

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

Article 20

Directive 71/316/EEC, as amended by the acts listed in Annex III, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.

Article 21

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 22

This Directive is addressed to the Member States.

Done at Strasbourg, 23 April 2009.

For the European Parliament

The President

H.-G. Pöttering

For the Council

The President

P. Nečas