Paragraph 14 Insertion of regulation 4(6A)

After regulation 4(6) insert—

“(6A)

In regulation 10 (CE marking of general medical devices)—

(a)

in the heading for “CE Marking” substitute “UK marking”;

(b)

in paragraph (1)—

(i)

in the opening words for “CE marking” substitute “UK marking”;

(ii)

in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008 ^f1” ;

(iii)

in sub-paragraph (c) for “notified body” substitute “approved body”;

(c)

in paragraph (2)—

(i)

in the opening words for “CE marking” substitute “UK marking”;

(ii)

in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008”;

(iii)

in sub-paragraph (c) for “notified body” substitute “approved body”;

(d)

in paragraph (3)—

(i)

in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”;

(ii)

in the words following sub-paragraph (b)—

(aa)

for “CE marking” substitute “UK marking”;

(bb)

for “notified body” substitute “approved body”;

(e)

in paragraph (4)—

(i)

in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”;

(ii)

in the words following sub-paragraph (b)—

(aa)

for “CE marking” substitute “UK marking”;

(bb)

for “notified body” substitute “approved body”;

(f)

in paragraph (5) in the words after sub-paragraph (c), for both references to “CE marking” substitute “UK marking”.”.