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SCHEDULE 2Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Substitution of regulation 8(2) and (3)

44.  For regulation 8(2) and (3) substitute—

(2) In regulation 53 (fees in connection with the registration of devices and changes in registration details) for “regulation 19 or 44” substitute “regulation 7A, 19, 21A, 33A or 44”.

(3) In regulation 54 (fees payable in connection with the designation of UK notified bodies)—

(a)for the heading substitute “Fees payable in connection with the designation of approved bodies”;

(b)in paragraph (1) for “a notified body” substitute “an approved body”;

(c)in paragraph (3) for “the Mutual Recognition Agreements” in both places substitute “a mutual recognition agreement”;

(d)in paragraph (3C) for “A UK notified body” substitute “An approved body”;

(e)in paragraph (3D)—

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

(ii)for “the UK notified body” substitute “the approved body”;

(f)in paragraph (3E) for “A UK notified body” substitute “An approved body”..