The Medical Devices (Amendment) Regulations 2013

Amendment of regulation 45 of the 2002 Regulations

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14.—(1) Regulation 45 of the 2002 Regulations (designation etc. of UK notified bodies) is amended as follows.

(2) In paragraph (2)(a) after “Annex 8 of that Directive” insert “, read with Regulation (EU) No 722/2012,”.

(3) In paragraph (2)(b) for “article 4 of Directive 2003/32” substitute “Regulation (EU) No 722/2012”.

(4) In paragraphs (5)(b), (7) and (8) for “read with article 4 of Directive 2003/32” substitute “both read with Regulation (EU) No 722/2012”.