The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

Substitution of regulation 4(9)

20.  For regulation 4(9) substitute—

“(9) In regulation 18 (UK notified bodies and the conformity assessment procedures for general medical devices)—

(a) in the heading, for “UK notified bodies” substitute “Approved bodies”;

(b) in paragraph (1)—

(i) in the opening words, for “A UK notified body” substitute “An approved body”;

(ii) in sub-paragraph (a) omit “in accordance with Directive 93/42”;

(iii) in sub-paragraph (b) omit the words “including in particular” to “EEA State”;

(c) in paragraph (2) for “a UK notified body” substitute “an approved body”;

(d) in paragraph (3)—

(i) for “a UK notified body” substitute “an approved body”;

(ii) for “his authorised representative”, in both places, substitute “the manufacturer’s UK responsible person”;

(e) omit paragraph (4).”.