Amendment of regulation 27 of the 2002 Regulations

11.  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).”