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(1) These Regulations may be cited as the Medical Devices (Amendment) Regulations 2012 and shall come into force on 1st July 2012.
(2) In these Regulations—““the 2002 Regulations” means the Medical Devices Regulations 2002 ”.
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Regulation 2 (interpretation) of the Medical Devices Regulations 2002 is amended as follows:
(a) in paragraph (1),
(i) for the definition of  “Directive 90/385”, substitute—““Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices .”.
(ii) For the definition of  “Directive 93/42”, substitute—““Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices .”.
(iii) For the definition of  “Directive 98/79”, substitute—““Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices .”.
(b) after paragraph (1), insert—“
(1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as amended from time to time.”.
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Signed by authority of the Secretary of State for Health.
Earl Howe

Parliamentary Under-Secretary of State,

Department of Health
