Paragraph 14

In regulation 30^f1 (manufacture etc. and conformity assessment procedures for active implantable medical devices)—

(a)

in paragraph (1), for “set out in Directive 90/385” substitute “in the Annexes referred to in regulation 27(a)”;

(b)

in paragraph (2)—

(i)

after “conformity assessment procedure” insert “in the Annexes referred to in regulation 27(a)”,

(ii)

omit “in accordance with Directive 90/385”.

Annotations

f1: Amended by S.I. 2008/2936, 2019/791 (as amended by S.I. 2020/1478) and S.I. 2020/1478.