Paragraph 29 Insertion of regulation 5(5A)

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”.”.