Paragraph 41 Insertion of regulation 6(9)

After regulation 6(8) insert—

“(9)

In paragraph 44 (registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation)—

(a)

in paragraph (1)—

(i)

in the opening words, for “Subject to paragraph (3), for” substitute “For”;

(ii)

in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”;

(iii)

in sub-paragraph (c) for “Community” each time that word occurs substitute “Great Britain”;

(iv)

in sub-paragraph (g)(ii) for “the United Kingdom” substitute “Great Britain”;

(b)

in paragraph (2)—

(i)

in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”;

(ii)

in sub-paragraph (b) for “the United Kingdom” in both places substitute “Great Britain”;

(iii)

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

(c)

omit paragraph (3).”.