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

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.