The Medical Devices (Amendment) Regulations 2012

• Citation: S.I. 2012/1426
• Sections: 3

Section 1 Citation, commencement and interpretation

(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

Section 2 Amendment of the Medical Devices Regulations 2002

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.

Section 3 Review

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