S.L. 427.44 Art. 1Citation.

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

(2) These regulations transpose the following Directives: *

(a) Council Directive 93/42/EEC of 14th June 1993 on the approximation of the laws of the Member States relating to medical devices; †

(b) Council Directive 2003/12/EC of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices; ‡

(c) Council Directive 2003/32/EC of 23rd April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/ EEC with respect to medical devices manufactured utilising tissues of animal origin; §

(d) Council Directive 2005/50/EC of 11th August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices;

(e) Directive 2007/47/EC** of the European Parliament and of the Council of 5th 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 will remain applicable:

(a) The placing on the market and putting into service of

*OJ No. L.169, 12-07-1993, p.1. 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 No. L.28, 04-02-2003, p.43. ‡OJ No. L.105, 26-04-2003, p.18. These regulations lay down detailed specifications in relation to risks of transmitting transmissible spongiform encephalopathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue. §OJ No.L.210, 12-08-2005, p.41. **OJ No. L.247, 21-09-2007, p.21. medical devices which have been subjected to EEC pattern approval in accordance with Directive 76/764/ EEC shall be accepted until 30th June 2004.

(b) The placing on the market of devices which conform to the rules in force in Malta on 31st December 1994 shall be accepted for a period of five years following the adoption of Directive 93/42/EEC. The putting into service of such devices shall be accepted until 30th June 2001 at the latest.

(c) Holders of EC design-examination certificates or EC type-examination certificates issued before 1st April 2004 for medical devices referred to in the definition for "medical device manufactured utilising tissues of animal origin" in regulation 3 shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in Schedule XIII.

(d) The placing on the market and the putting into service of medical devices referred to in definition for "medical device manufactured utilising tissues of animal origin" in regulation 3 which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1st April 2004 shall be accepted until 20th September 2004.

(e) Breast implants placed on the market before 1st September 2003 pursuant to regulation 6(3)(a) or 6(3)(b)(iii) shall be subject to a conformity reassessment procedure as Class III medical devices before 1st March 2004.

(f) By way of derogation from regulation 6(10), the decisions on breast implants taken by the notified bodies before 1st September 2003 under regulation 6(3)(a) may not be extended.

(g) Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to regulation 6(3)(a) before 1st September 2007 shall be subject to a complementary conformity assessment under section 4 of Schedule II leading to an EC design-examination certificate before 1st September