Amendment of the Medical Devices Regulations 2002

3.—(1) The Medical Devices Regulations 2002(1) are amended as follows.

(2) In regulation 54 (fees payable in connection with the designation etc of UK notified bodies)—

(a) in paragraph (1)—

(i) in sub-paragraph (a), for “£900” substitute “£930”; and

(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;

(b) in paragraph (2), for “£1,800” substitute “£1,810”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£4,400” substitute “£4,500”;

(ii) in sub-paragraph (b)(i), for “£7,200” substitute “£7,400”;

(iii) in sub-paragraph (b)(ii), for “£5,400” substitute “£5,550”;

(iv) in sub-paragraph (b)(iii), for “£3,600” substitute “£3,700”; and

(v) in sub-paragraph (c), for “£3,600” substitute “£3,700”; and

(d) in paragraph (3A)—

(i) in sub-paragraph (a)(i), for “£254” substitute “£261”; and

(ii) in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.

(3) In regulation 55 (fees payable in connection with the designation etc of EC conformity assessment bodies)—

(a) in paragraph (1)—

(i) in sub-paragraph (a), for “£900” substitute “£930”; and

(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;

(b) in paragraph (2), for “£1,800” substitute “£1,810”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£4,400” substitute “£4,500”;

(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;

(iii) in sub-paragraph (c), for “£1,800” substitute “£1,810”; and

(iv) in sub-paragraph (d), for “£3,600” substitute “£3,700”;

(d) in paragraph (3A), for “£4,400” substitute “£4,500” and for “£1,800” substitute “£1,810”;

(e) in paragraph (3B), for “£3,600” substitute “£3,700” and for “£1,800” substitute “£1,810”;

(f) in paragraph (3C), for “£1,800” substitute “£1,810”; and

(g) in paragraph (3D)—

(i) in sub-paragraph (a)(i), for “£254” substitute “£261”; and

(ii) in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.

(4) In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (1)—

(a) in sub-paragraph (a), for “£2,100” substitute “£2,120” and for “£2,700” substitute “£2,770”; and

(b) in sub-paragraph (b), for “£3,000” substitute “£3,020” and for “£4,100” substitute “£4,240”.

(1)

S.I. 2002/618; relevant amendments have been made by S.I. 2003/1697, 2007/803 and 2008/530.