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

Insertion of regulation 5(5A)

29.  After regulation 5(5) insert—

“(5A) In regulation 27 (procedures for affixing a CE marking to active implantable medical devices)—

(a) in the heading for “CE marking” substitute “UK marking”;

(b) in the opening words for—

(i) “CE marking” substitute “UK marking”;

(ii) “his authorised representative” substitute “their UK responsible person”;

(c) in sub-paragraphs (b) and (c) for “Directive 90/385” substitute “this Part”.”.