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”.