The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Amendment of Part VI of the 2002 Regulations

8.—(1) Part VI of the 2002 Regulations is amended as follows.

(2) In regulation 53(1) (Fees in connection with the registration of devices and changes in registration details)—

(a) for “regulation 19 or 44” substitute “regulations 7A, 19, 21A, 33A, 44, 93, 95, 158 or 160”;

(b) after “registration of that person” insert “or, in the case of registration of a device, the device”.

(3) In regulation 54(2) (Fees payable in connection with the designation of UK notified bodies)—

(a) in the heading omit “with the designation etc. of”;

(b) for “the Mutual Recognition Agreements” in both places, substitute “a mutual recognition agreement”;

(c) omit paragraph (1);

(d) omit paragraph (3C);

(e) in paragraph (4), omit sub-paragraph (a).

(4) In regulation 55(3) (Fees payable in connection with the designation etc. of EC conformity assessment bodies —

(a) in the heading and in every other place it occurs omit “EC”;

(b) in paragraph (3), for “the Mutual Recognition Agreements”, substitute “a mutual recognition agreement”.

(5) In regulation 58 (Waivers, reductions and refunds) in paragraph (2)—

(a) at the end of sub-paragraph (a) omit “or”;

(b) omit sub-paragraph (b);

(c) after sub-paragraph (b) in the full out words omit from “(other than” to “the Secretary of State”.

(1)

Regulation 53 was amended by S.I. 2017/207.

(2)

Regulation 54 was amended by S.I. 2003/1697, S.I. 2007/803, S.I. 2013/2327, S.I. 2017/207.

(3)

Regulation 55 was amended by S.I. 2007/803, S.I. 2010/557 and S.I. 2017/207.