Regulation 4 Amendment of regulation 13 of the 2002 Regulations
(1)
Regulation 13 of the 2002 Regulations (procedures for affixing a CE marking to general medical devices) is amended as follows.
(2)
In paragraph (4)—
(a)
in sub-paragraph (b) omit “and”;
(b)
at the end of sub-paragraph (c) add “and”; and
(c)
after sub-paragraph (c) add the following sub-paragraph—
“(d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).”
(3)
Omit paragraphs (5) and (6).