The Medical Devices (Fees Amendments) Regulations 2008

• Citation: S.I. 2008/530
• Sections: 3

Section 1 Citation and commencement

These Regulations may be cited as The Medical Devices (Fees Amendments) Regulations 2008 and shall come into force on 1 st April 2008.

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 “£4,141” substitute “”£4,374”, and

(ii) in sub-paragraph (b), for “£9,653” substitute “£10,197”;

(b) in paragraph (2)—

(i) in sub-paragraph (a), for “£819” substitute “£865”, and

(ii) in sub-paragraph (b), for “£2,291” substitute “£2,420”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£4,141” substitute “£4,374”, and

(ii) in sub-paragraph (b), for “”£9,653” substitute “£10,197”;

(d) in paragraph (4)—

(i) in sub-paragraph (a), for “£819” substitute “£865”, and

(ii) in sub-paragraph (b), for “£2,291” substitute “ £2,420”;

(e) in paragraph (5)—

(i) in sub-paragraph (a), for “£42,352” substitute “£44,741”, and

(ii) in sub-paragraph (b), for “£10,515” substitute “£11,108”.

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

(a) in sub-paragraph (a), for “£750” substitute “£792”;

(b) in sub-paragraph (b), for “£950” substitute “£1,004”;

(c) in sub-paragraph (c) for “£1,300” substitute £1,373”; and

(d) for “(a) if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,650” substitute—

(d) if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,173

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 “£850” substitute “£900”, and

(ii) in sub-paragraph (b), for “£3,400” substitute “£3,600”;

(b) in paragraph (2), for “£1,700” substitute “£1,800”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£4,200” substitute “£4,400”,

(ii) in sub-paragraph (b)(i), for “£6,800” substitute “£7,200”,

(iii) in sub-paragraph (b)(ii), for “£5,100” substitute “£5,400”,

(iv) in sub-paragraph (b)(iii), for “£3,400” substitute “£3,600”; and

(v) in sub-paragraph (c), for “£3,400” substitute “£3,600”; and

(d) in paragraph (3A)—

(i) in sub-paragraph (a)(i), for “£240” substitute “£254”, and

(ii) in sub-paragraph (a) (ii), for “£67.10” substitute “£70.45”.

(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 “£850” substitute £900”, and

(ii) in sub-paragraph (b), for “£3,400” substitute “£3,600”;

(b) in paragraph (2), for “£1,700” substitute “£1,800”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£4,200” substitute “£4,400”,

(ii) in sub-paragraph (b), for “£3,400” substitute “£3,600”,

(iii) in sub-paragraph (c), for “£1,700” substitute “£1,800”, and

(iv) in sub-paragraph (d), for “£3,400” substitute “£3,600”;

(d) in paragraph (3A), for “£4,200” substitute “£4,400” and for “£1,700” substitute “£1,800”;

(e) in paragraph (3B), for “£3,400” substitute “£3,600” and for “£1,700” substitute “£1,800”;

(f) in paragraph (3C), for “£1,700” substitute “£1,800”; and

(g) in paragraph (3D)—

(i) in sub-paragraph (a)(i), for “£240” substitute “£254”, and

(ii) in sub-paragraph (a) (ii), for “£67.10” substitute “£70.45”.

(4) In regulation 56 (fees payable in relation to clinical investigations), in paragraph (1)-

(a) in sub-paragraph (a)—

(i) in sub-paragraph (i), for “£1,800” substitute “£2,100”, and

(ii) in sub-paragraph (ii), for “£2,400” substitute “£2,700”; and

(b) in sub-paragraph (b)—

(i) in sub-paragraph (i), for “£2,700”substitute “£3,000”, and

(ii) in sub-paragraph (ii), for “£3,800” substitute “£4,100”.