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

Amendment of regulation 7 (amendment of Part V of the 2002 Regulations)

6.—(1) Regulation 7 is amended as follows.

(2) For paragraph (4), substitute—

“(4) In regulation 48 (designation etc. of EC conformity assessment bodies)—

(a) in the heading omit “EC”;

(b) in paragraph (1)—

(i) omit “European Community”;

(ii) for “an “EC CAB”” substitute “a “CAB””;

(c) in paragraphs (2), (4), (5), (7) and (8), for “an EC CAB”, in each place it occurs, substitute “a CAB”;

(d) in paragraph (6), omit “EC” in both places;

(e) in paragraphs (1), (2), (5), (7) and (8), for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”.”.

(3) For paragraph (5), substitute—

“(5) In regulation 49 (fees charged by UK notified bodies and EC conformity assessment bodies)—

(a) in the heading omit “EC”;

(b) in paragraph (1)—

(i) for “or EC CAB” substitute “or CAB”;

(ii) in sub-paragraphs (a) and (b), for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(iii) in sub-paragraph (b), for “an EC CAB” in both places it occurs, substitute “a CAB”;

(c) in paragraphs (3) and (4), for “or EC CAB” substitute “or CAB”.”.