The Medical Devices (Fees Amendments) Regulations 2009

• Citation: S.I. 2009/383
• Sections: 3

Section 1 Citation and commencement

These Regulations may be cited as the Medical Devices (Fees Amendments) Regulations 2009 and shall come into force on 1st April 2009.

Section 2 Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

(1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 are amended as follows.

(2) In regulation 3 (fees)—

(a) in paragraph (1)—

(i) in sub-paragraph (a), for “£4,374” substitute “£4,549”; and

(ii) in sub-paragraph (b), for “£10,197” substitute “£10,605”;

(b) in paragraph (2)—

(i) in sub-paragraph (a), for “£865” substitute “£900”; and

(ii) in sub-paragraph (b), for “£2,420” substitute “£2,517”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£4,374” substitute “£4,549”; and

(ii) in sub-paragraph (b), for “£10,197” substitute “£10,605”;

(d) in paragraph (4)—

(i) in sub-paragraph (a), for “£865” substitute “£900”; and

(ii) in sub-paragraph (b), for “£2,420” substitute “£2,517”; and

(e) in paragraph (5)—

(i) in sub-paragraph (a), for “£44,741” substitute “£46,531”; and

(ii) in sub-paragraph (b), for “£11,108” substitute “£11,552”.

(3) In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—

(a) in sub-paragraph (a), for “£792” substitute “£824”;

(b) in sub-paragraph (b), for “£1,004” substitute “£1,044”;

(c) in sub-paragraph (c), for “£1,373” substitute “£1,428”; and

(d) in sub-paragraph (d), for “£1,173” substitute “£1,813”.

Section 3 Amendment of the Medical Devices Regulations 2002

(1) The Medical Devices Regulations 2002 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”.