Paragraph 41 Insertion of regulation 6(5A)

After regulation 6(5) insert—

“(5A)

In regulation 40 (procedures for affixing a CE marking to in vitro diagnostic medical devices)—

(a)

in the heading and in each place in that regulation that “CE marking” occurs substitute “UK marking”;

(b)

for “his authorised representative”, each time those words occur, substitute “their UK responsible person”;

(c)

for each reference to “Directive 98/79” substitute “this Part”.”.