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

Amendment of regulation 49

This section has no associated Explanatory Memorandum

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

(a)for the heading substitute “Fees charged by UK notified bodies and conformity assessment bodies”;

(b)in the opening words of paragraph (1) for “EC CAB” substitute “CAB”;

(c)in paragraph (1)(a) for “the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure set out in the Medical Devices Directives” substitute “the Medical Devices Directives or a UK mutual recognition agreement in respect of a conformity assessment procedure set out in the Medical Devices Directives or these Regulations as they apply in Great Britain”;

(d)in paragraph (1)(b)—

(i)for “an EC CAB” in both places substitute “a CAB”;

(ii)for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”;

(e)in paragraph (3) for “EC CAB” substitute “CAB”;

(f)in paragraph (4) for “EC CAB” substitute “CAB”.