S.L. 427.10 ст. 2Scope.

(1) These regulations shall apply to active implantable medical devices.

(2) (a) For the purposes of these regulations, the Medicines Authority will act as the Maltese national competent authority in terms of the Committee referred to in Article 6 of Directive 93/42/EEC and with respect to the exchange of information, necessary to enable these regulations to be applied uniformly, with other Member States and the Commission.

(b) For the purposes of these regulations, the Medicines Authority will act as Malta’s national competent authority with respect to exchange of experience organised by the Commission in order to coordinate the uniform application of these regulations.