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Paragraph 11

Original text. Later amendments are not shown.

In Article 4 (which relates to verification of the fitness of notified bodies, which are now approved bodies)—

(a)

for paragraph 1 substitute—

“The Secretary of State must verify on a regular basis that approved bodies designated under Part 5 of the Medical Devices Regulations 2002 have up-to-date knowledge and expertise of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices with the provisions of those Regulations and with the particular requirements of Annex I to this Regulation.”;

(b)

omit paragraph 2.