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

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.