S.L. 427.44 Art. 11Registration of persons responsible for placing devices on the market.

(1)(a) Any manufacturer who has his registered place of business in Malta and, under his own name, places devices on the market in accordance with the procedures referred to in regulation 6(4) and (5) and any other natural or legal person engaged in the activities referred to in regulation 8(1) to (5) shall inform the Medicines Authority of his registered place of business and the description of the devices concerned.

(b) For all medical devices of Classes IIa, IIb and III, all data allowing the identification of such devices together with the label and instructions for use, may be requested when such devices are put into service in Malta.

(2) (a) Where a manufacturer who places a device on the Maltese or Community 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.

(b) When the authorised representative referred to herein has a registered place of business in Malta, he shall inform the Regulatory Affairs Directorate of the details referred to in sub-regulation (1).

(3) The Medicines Authority shall, on request, inform the other Member States and the Commission of the details referred to in sub-regulations (1) and (2) given by the manufacturer or authorised representative.