Paragraph 23 Insertion of regulation 4(10)

After regulation 4(9) insert—

“(10)

In regulation 19 (registration of persons placing general medical devices on the market)—

(a)

in paragraphs (1), (3), (4) and (5) for “Subject to paragraph (6), for” substitute “For”;

(b)

in paragraph (2)(a) for “CE marked” substitute “UK marked”;

(c)

in paragraphs (2)(a) and (b) for “the United Kingdom” in each place substitute “Great Britain”;

(d)

in paragraph (3)—

(i)

in the opening words for—

(aa)

“the United Kingdom” in both places substitute “Great Britain”;

(bb)

“the Community or in a State which is a Party to an Association Agreement” substitute “the United Kingdom”;

(ii)

omit sub-paragraph (c) and “;and” which precedes it;

(e)

in paragraph (4), in the opening words for—

(i)

“the United Kingdom” in both places substitute “Great Britain”;

(ii)

“CE marked” substitute “UK marked”;

(f)

in paragraph (5)—

(i)

for “the United Kingdom” in each place substitute “Great Britain”;

(ii)

omit “(including the authorised representative of a manufacturer of a Class IIa, IIb or III device who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement)”;

(g)

omit paragraph (6).”.