Regulation 11 Amendment of regulation 27 of the 2002 Regulations

In regulation 27 of the 2002 Regulations (procedures for affixing a CE marking to active implantable medical devices)—

(a)

in paragraph (b) omit “and”;

(b)

at the end of paragraph (c) add “and”; and

(c)

after paragraph (c) add the following paragraph—

“(d)
fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).”