Article 14Registration of persons responsible for placing devices on the market

1

Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.

F2For all medical devices of F1classes IIa, IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.

F12

Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.

F13

The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.