SCHEDULE 2Amendment 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”.