# The Medical Devices (Amendment) Regulations 2012, Regulation 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.”.

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Source: https://www.legislation.gov.uk/uksi/2012/1426/regulation/2 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-regulations-2012/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.