Amendment of regulation 27 of the 2002 Regulations11
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).