S.L. 427.10 Art. 1Citation.

(1) The title of these regulations is Active Implantable Medical Devices Regulations.

(2) These regulations transpose the following Directives: *

(a) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices; and †

(b) Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/ EEC concerning medical devices and Directive 98/8/ EC concerning the placing of biocidal products on the market.

(3) The following transitional measures shall remain applicable:

(a) CE marking shall not be obligatory prior to the 1st October 2001 in respect of stocks of active implantable medical devices already placed on the market prior to 1st April 2001 and active implantable medical devices ordered before 1st April 2001 and imported into Malta up to 30th September 2001; and

(b) The provisions of these regulations shall not apply to contracts made before 1st April 2001, covering the supply of active implantable medical devices to the Government of Malta over the period up to and including 31st December 2002, as well as those contracts which had terminated before 1st April 2001 or which, before 1st April 2001, were determined or dissolved by agreement or by a judgement which had become a res judicata, or by operation of the law; in respect of such contracts the law applicable at the time, including the time of their termination, determination or dissolution, shall in so far as necessary, continue to apply.

*OJ L.189, 20-07-1990, p.17. Directive as last amended by Regulation (EC) No 1882/ 2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty (OJ No. L. 284, 31-10-2003, p.1). †OJ L.247, 21-09-2007, p.21.