The Medical Devices Regulations 2002

Changes over time for: Section 55

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Changes to legislation:

The Medical Devices Regulations 2002, Section 55 is up to date with all changes known to be in force on or before 11 June 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.

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Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.

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Changes and effects yet to be applied to Regulation 55:

reg. 55 heading word omitted by S.I. 2019/791 reg. 8(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 8(4) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 2 para. 7)
reg. 55 word omitted by S.I. 2019/791 reg. 8(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 8(4) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 2 para. 7)
reg. 55(1)(a) word substituted by S.I. 2007/610 reg. 13(3)(a)(i)
reg. 55(1)(b) word substituted by S.I. 2007/610 reg. 13(3)(a)(ii)
reg. 55(2) word substituted by S.I. 2007/610 reg. 13(3)(b)
reg. 55(3) words inserted by S.I. 2007/610 reg. 13(3)(c)(i)
reg. 55(3) words substituted by S.I. 2019/791 reg. 8(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 8(4) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 2 para. 7)
reg. 55(3)(a)-(d) substituted for reg. 55(3)(a)-(c) by S.I. 2007/610 reg. 13(3)(c)(ii)
reg. 55(3A)-(3D) inserted by S.I. 2007/610 reg. 13(3)(d)

Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:

Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):

Pt. 8 inserted by S.I. 2019/791 reg. 10 (This amendment not applied to legislation.gov.uk. Reg. 10 omitted immediately before IP completion day by virtue of S.I. 2020/1478, regs. 1(3), Sch. 2 para. 54)
Pt. 9 inserted by S.I. 2019/791 reg. 11 (This amendment not applied to legislation.gov.uk. Reg. 11 omitted immediately before IP completion day by virtue of S.I. 2020/1478, regs. 1(3), Sch. 2 para. 55)
Sch. 3 inserted by 2021 c. 3 Sch. 3 para. 2
Sch. 19 para. 5 words substituted by S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(2)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
Sch. 19 para. 5 words substituted by S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(2)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
Sch. 24 para. 1(7) heading words omitted by virtue of S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
Sch. 24 para. 1(7) words omitted by virtue of S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 4D(10)(b) substituted by S.I. 2019/791, reg. 3(7) (as amended) by S.I. 2019/1385 Sch. 2 para. 2(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(a)(ii))
reg. 4E(7) words substituted by S.I. 2019/791, reg. 3(7) (as amended) by S.I. 2019/1385 Sch. 2 para. 2(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(a)(ii))
reg. 6(d) inserted by S.I. 2019/791 reg. 4(2) (This amendment not applied to legislation.gov.uk. Reg. 4(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 10)
reg. 33(1)(c) inserted by S.I. 2019/791 reg. 6(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 6(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 35)
reg. 33(2)(c) inserted by S.I. 2019/791 reg. 6(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 6(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 35)
reg. 60A excluded by 2021 c. 3 Sch. 2 para. 4
reg. 60A excluded by 2021 c. 3 Sch. 2 para. 5(2)
reg. 60A-60C inserted by 2021 c. 3 Sch. 3 para. 1
reg. 75(3) words inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(2)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 75(7) inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(2)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 93(4) inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(3) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 119(6) words inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(4) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 124(5) words substituted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(5) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 149(5)(e) words substituted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(2) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 158(1) substituted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
reg. 158(3) inserted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))

F1 Fees payable in connection with the designation etc. of ... conformity assessment bodiesE+W+S

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as [F2a CAB] shall, in connection with that application for designation, pay to the Secretary of State—

(a)if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of [F3£8,918]; or

(b)in all other cases, a fee of [F4£35,672].

[F5(2) A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

(a)in respect of an extension to the scope of the body’s designation to carry out tasks arising out of a mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of £12,571; or

(b)in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of £18,212.]

(3) [F6Subject to paragraphs (3A) to (3C)] where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of [F7a CAB] arising out of [F8a mutual recognition agreement] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F9(a)in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of [F10£58,341] plus the amounts specified in paragraph (3D);

(b)in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of [F11£10,072] plus the amounts specified in paragraph (3D);

(c)in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of [F12£1,880];

(d)in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F13£10,072 ] plus the amounts specified in paragraph (3D).]

[F14(3A) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be [F15£58,341] plus—

(a)[F16£1,880] for each additional inspection; and

(b)the amounts specified in paragraph (3D).

(3B) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be [F17£10,072 ] plus—

(a)[F18£1,880] for each additional inspection; and

(b)the amounts specified in paragraph (3D)

(3C) Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be [F19£1,880] for each inspection.

(3D) The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

(a)an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)for the time spent on site, of [F20£631] per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)for the time spent travelling to and from the site, of [F21£171] per hour;

(b)the actual costs of travel, accommodation and subsistence, and

(c)out of pocket expenses.]

(4) A fee under this regulation—

(a)in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

(i)shall be payable when the application to the Secretary of State is made, and

(ii)shall accompany the application when it is made;

(b)in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1Word in reg. 55 heading omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(a) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F2Words in reg. 55(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(b) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F3Sum in reg. 55(1)(a) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(2)(a)

F4Sum in reg. 55(1)(b) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(2)(b)

F5Reg. 55(2) substituted (E.W.S) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(3)

F6Words in reg. 55(3) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(i)

F7Words in reg. 55(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(c)(i) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F8Words in reg. 55(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(c)(Ii) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F9Reg. 55(3)(a)-(d) substituted for reg. 55(3)(a)-(c) (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(ii)

F10Sum in reg. 55(3)(a) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(4)(a)

F11Sum in reg. 55(3)(b) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(4)(b)

F12Sum in reg. 55(3)(c) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(c)(iii)

F13Sum in reg. 55(3)(d) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(4)(b)

F14Reg. 55(3A)-(3D) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(d)

F15Sum in reg. 55(3A) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(5)

F16Sums in reg. 55(3A) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(d)

F17Sum in reg. 55(3B) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(6)

F18Sums in reg. 55(3B) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(e)

F19Sum in reg. 55(3C) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(f)

F20Sum in reg. 55(3D)(a)(i) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(7)(a)

F21Sum in reg. 55(3D)(a)(ii) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(7)(b)

F22 Fees payable in connection with the designation etc. of ... conformity assessment bodiesN.I.

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as [F23a CAB] shall, in connection with that application for designation, pay to the Secretary of State—

(a)if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of [F24£8,918]; or

(b)in all other cases, a fee of [F25£35,672].

[F26(2) A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

(a)in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out tasks arising out of a UK mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of £12,571; or

(3) [F27Subject to paragraphs (3A) to (3C)] where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of [F28a CAB] arising out of [F29a UK mutual recognition agreement] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F30(a)in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of [F31£58,341] plus the amounts specified in paragraph (3D);

(b)in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of [F32£10,072 ] plus the amounts specified in paragraph (3D);

(c)in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of [F33£1,880];

(d)in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F34£10,072] plus the amounts specified in paragraph (3D).]

[F35(3A) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be [F36£58,341] plus—

(a)[F37£1,880] for each additional inspection; and

(b)the amounts specified in paragraph (3D).

(a)[F39£1,880] for each additional inspection; and

(b)the amounts specified in paragraph (3D)

(3D) The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

(a)an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)for the time spent on site, of [F41£631] per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)for the time spent travelling to and from the site, of [F42£171] per hour;