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

Amendment of Part V of the 2002 Regulations

This section has no associated Explanatory Memorandum

7.—(1) Part V of the 2002 Regulations is amended as follows.

(2) In regulation 45(1) (Designation etc. of UK notified bodies)—

(a)in the heading, omit “Designation etc. of”;

(b)for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”;

(c)omit paragraphs (1) to (3);

(d)in paragraph (5)—

(i)in the introductory wording, omit “under paragraph (1)”;

(ii)in sub-paragraph (c) omit “under paragraph (1)”.

(3) In regulation 47(2)—

(a)in paragraph (1)—

(i)for “an application has been made” substitute “, before exit day, an application was made”;

(ii)for “shall perform those functions”, substitute “shall perform the functions set out in regulations 4F(8)(b) and 4G(8)(b)”;

(b)in paragraph (3)—

(i)for the first mention of “notified body” substitute “UK notified body”;

(ii)omit “, if the notified body is within the United Kingdom,”;

(iii)omit “or some other Community language acceptable to the notified body concerned”;

(c)in paragraph (5), for “notified body” in both places it occurs substitute “UK notified body”;

(d)in paragraphs (6) and (8), for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”.

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

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

(b)for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”;

(c)in paragraph (1) omit “European Community”.

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

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

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

(c)in paragraph (1), for “under the Medical Devices Directives”, substitute “under these Regulations”.

(1)

Regulation 45 was amended by S.I. 2003/1697 and S.I. 2013/2327.

(2)

Regulation 47 was amended by S.I. 2008/2936 and S.I. 2013/2327.