Paragraph 51 Substitution of regulation 9(4)

For regulation 9(4) substitute—

“(4)

In regulation 61 (enforcement etc.)—

(a)

for “CE marking” in both places substitute “UK marking”;

(b)

in paragraph (8)(a)(i), after “essential requirement” insert “, a general safety and performance requirement”;

(c)

in paragraph (8)(a)(ii), omit “set out in the Medical Devices Directives”;

(d)

in paragraph (8)(a)(ii)(aa), for “his authorised representative” substitute “their UK responsible person”.”.