Paragraph 17 Insertion of regulation 4(7A)

After regulation 4(7) insert—

“(7A)

In regulation 13 (procedures for affixing a CE marking to general medical devices)—

(a)

in the heading for “CE marking” substitute “UK marking”;

(b)

for each reference to “Directive 93/42” substitute “this Part”;

(c)

for “CE marking”, each time those words occur, substitute “UK marking”;

(d)

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