PART VI E+W+S Fees charged by the Secretary of State

Interpretation of Part VI U.K.

52.—(1) In this PartF1 ...—

• [F2 “approved manufacturer” in relation to a medicinal substance means a manufacturer who—

  (a)

  holds a manufacturing authorisation which permits the manufacturer to manufacture that substance for inclusion in an authorised medicinal product; or

  (b)

  holds an examination certificate for a device incorporating that medicinal substance and that certificate was issued by an approved body or notified body after consultation with the Secretary of State in respect of that substance;]

• [F2 “authorised medicinal product” means a medicinal product in respect of which a marketing authorisation has been granted;]

• [F2 “clinical development” means the conduct of studies of a medicinal substance in human subjects in order to—

  (a)

  discover or verify the effects of such a substance,

  (b)

  identify any adverse reaction to such a substance, or

  (c)

  study absorption, distribution, metabolism and excretion of such a substance,

  with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with section 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385;]

• [F2 “consultation” means a consultation required by—

  (a)

  section 4.3 of Annex II of Directive 93/42 or Directive 90/385; or

  (b)

  section 5 of Annex III of Directive 93/42 or Directive 90/385;]

• [F2 “examination certificate” means—

  (a)

  a design-examination certificate within the meaning of sections 4.3 and 4.4 of Annex II of Directive 93/42 or Directive 90/385, issued by an approved body;

  (b)

  a type-examination certificate within the meaning of sections 5 and 6 of Annex III of Directive 93/42 or Directive 90/385, issued by an approved body;

  (c)

  an EC design-examination certificate within the meaning of sections 4.3 and 4.4 of the version of Annex II of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day, issued by a notified body; or

  (d)

  an EC type-examination certificate within the meaning of sections 5 and 6 of the version of Annex III of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day), issued by a notified body;]

• [F2 “further consultation” means a consultation by an approved body in relation to any device which—

  (a)

  may be placed on the market or put into service in accordance with Part 2 or 3 and which is the subject of an examination certificate issued by that approved body after consultation with the Secretary of State;

  (b)

  is the subject of proposed changes within section 4.4 of Annex II of Directive 93/42 or Directive 90/385 or section 6 of Annex III of Directive 93/42 or Directive 90/385 and if that device is to be placed on the market or put into service, those changes may require a supplement to the examination certificate previously issued by that approved body after consultation with the Secretary of State; or

  (c)

  is of a similar design or type to a device which has been the subject of an unsuccessful application for an examination certificate where—

  (i)

  the person who made that unsuccessful application makes a further application for an examination certificate to the approved body which determined that unsuccessful application; and

  (ii)

  within the relevant period that further application becomes the subject of consultation between that approved body and the Secretary of State;]

• “Group A device” means a Class I medical device, a Class IIa medical device, or a Class IIb medical device which is neither an implantable device nor a long term invasive medical device;

• “Group B device” means a Class IIb medical device which is either an implantable medical device or a long term invasive medical device, or a Class III medical device, or an active implantable medical device; and “half day” means a period of three and a half hours.

• [F2 “incorporates” means incorporates as an integral part;]

• [F2 “marketing authorisation” has the meaning given by regulation 8 of the Human Medicines Regulations 2012;]

• [F2 “medicinal substance” means a substance which, if used separately from a device, may be considered to be a medicinal product, as defined in Schedule 1 to the Medicines (Products for Human Use) Fees Regulations 2016;]

• [F2 “new medicinal substance” means a medicinal substance which is not—

  (a)

  an authorised medicinal product;

  (b)

  an ingredient or, as the case may be, the sole active ingredient of such a product; or

  (c)

  a substance which has been incorporated in a device in respect of which an examination certificate has been issued by an approved body which has consulted the Secretary of State;]

• [F2 “quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385;]

• [F2 “relevant period” means the period of 5 years which starts on the first day on which the Secretary of State was consulted in respect of the unsuccessful application or, if there has been more than one such application in any particular case, in respect of the first of them;]

• [F2 “safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385; and]

• [F2 “scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a device.]

(2) For the purposes of this Part, medical devices are classified as being implantable or long term invasive medical devices in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42, and in the event of a dispute over the classification of a device, the Secretary of State shall determine the classification of the device in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42.

Textual Amendments

F1 Words in reg. 52(1) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 15

F2 Words in reg. 52(1) inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 7

Fees in connection with the registration of devices and changes to registration details E+W+S

53.  Any person required to supply the Secretary of State with any information under [F3 regulation 7A, 19, 21A, 33A or 44] shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of [F4 £240], and that fee—

(a) shall be payable when the information is supplied by that person to the Secretary of State; and

(b) shall accompany that information when it is supplied.

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F3 Words in reg. 53 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(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F4 Sum in reg. 53 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), 8

Fees in connection with the registration of devices and changes to registration details N.I.

53.  Any person required to supply the Secretary of State with any information under regulation 19 [F73 , 21B] or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of [F74 £240], and that fee—

(a) shall be payable when the information is supplied by that person to the Secretary of State; and

(b) shall accompany that information when it is supplied.

Extent Information

E5 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F73 Word in reg. 53 inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 20

F74 Sum in reg. 53 substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 9

[F5 Fees payable in connection with the designation of approved bodies] E+W+S

54.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as [F6 an approved body] 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 [F7 £8,918]; or

(b) in all other cases, a fee of [F8 £35,672].

[F9 (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 45(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 under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of £12,571;

(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 where the Secretary of State considers that an additional assessment of the body’s procedures is required, a fee of £18,212.]

(3) Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F10 both read with Regulation (EU) No 722/2012] or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of [F11 a mutual recognition agreement] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F12 (a) in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of [F13 £58,341] plus the amounts specified in paragraph (3A);

[F14 (b) in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of £45,675, plus the amounts specified in paragraph (3A); and]

(c) in respect of an inspection pursuant to regulation 45(7)(b), a fee of [F15 £10,072] plus the amounts specified in paragraph (3A).]

[F16 (3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) 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 [F17 £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 [F18 £171] per hour;

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

(c) out of pocket expenses.

(3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

(a) the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

(b) the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).]

[F19 (3C) [F20 An approved body] that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

(a) a fee of [F21 £35,672 ] in respect of the application; and

(b) where an audit is carried out in connection with the application, a fee of [F22 £58,341] in respect of the audit [F23 ,

plus the amounts specified in paragraph (3A).]

(3D) Where the Secretary of State conducts an assessment of [F24 an approved body] pursuant to article 5 of Regulation (EU) No 920/2013, [F25 the approved body] shall pay to the Secretary of State—

(a) if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of [F26 £18,583]; or

(b) in any other case, a fee of [F27 £22,789] [F28 ,

plus the amounts specified in paragraph (3A).]

(3E) [F29 An approved body] that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of [F30 £1,297].]

[F31 (3F) Where, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of £22,789, plus the costs and expenses referred to in paragraph (3A).]

(4) A fee under this regulation—

(a) in connection with an application for designation under [F32 regulation 45(1),] a variation under regulation 45(4)[F33 , a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012]—

(i) shall be payable when the application [F34 or submission] to the Secretary of State is made, and

(ii) shall accompany the application [F35 or submission] when it is made;

(b) in connection with an inspection pursuant to regulation 45(7) [F36 or an audit or assessment pursuant to Regulation (EU) No 920/2013], 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.

[F37 (5) In this regulation—

“Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and

“subsidiary” is to be construed in accordance with section 1159 of the Companies Act 2006.]

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F5 Reg. 54 heading 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(3)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 54(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(3)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F7 Sum in reg. 54(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), 10(2)(a)

F8 Sum in reg. 54(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), 10(2)(b)

F9 Reg. 54(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), 10(3)

F10 Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16

F11 Words in reg. 54(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(3)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F12 Reg. 54(3)(a)-(c) substituted (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(2)(c)

F13 Sum in reg. 54(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), 10(4)(a)

F14 Reg. 54(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), 10(4)(b)

F15 Sum in reg. 54(3)(c) 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), 10(4)(c)

F16 Reg. 54(3A)(3B) 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(2)(d)

F17 Sum in reg. 54(3A)(a)(i) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(5)(a)

F18 Sum in reg. 54(3A)(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), 10(5)(b)

F19 Reg. 54(3C)-(3E) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(6)

F20 Words in reg. 54(3C) 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(3)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F21 Sum in reg. 54(3C)(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), 10(6)(a)

F22 Sum in reg. 54(3C)(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), 10(6)(b)

F23 Words in reg. 54(3C) inserted (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), 10(6)(c)

F24 Words in reg. 54(3D) 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(3)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in reg. 54(3D) 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(3)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F26 Sum in reg. 54(3D)(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), 10(7)(a)

F27 Sum in reg. 54(3D)(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), 10(7)(b)

F28 Words in reg. 54(3D) inserted (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), 10(7)(c)

F29 Words in reg. 54(3E) 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(3)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F30 Sum in reg. 54(3E) 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), 10(8)

F31 Reg. 54(3F) inserted (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), 10(9)

F32 Words in reg. 54(4)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(i)

F33 Words in reg. 54(4)(a) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(ii)

F34 Words in reg. 54(4)(a)(i) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

F35 Words in reg. 54(4)(a)(ii) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

F36 Words in reg. 54(4)(b) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(b)

F37 Reg. 54(5) 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), 10(10)

Fees payable in connection with the designation etc. of UK notified bodies N.I.

54.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as a notified body 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 [F75 £2,063]; or

(b) in all other cases, a fee of [F76 £8,252].

(2) A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of [F77 £6,504].

(3) Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F78 both read with Regulation (EU) No 722/2012] or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F79 (a) in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of [F80 £15,904] plus the amounts specified in paragraph (3A);

(b) in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection—

(i) if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of [F81 £10,160],

(ii) if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of [F81 £10,160], or

(iii) if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, a fee of [F81 £10,160],

plus the amounts specified in paragraph (3A); and

(c) in respect of an inspection pursuant to regulation 45(7)(b), a fee of [F82 £4,404] plus the amounts specified in paragraph (3A).]

[F83 (3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) 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 [F84 £361.20] 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 [F85 £90.30] per hour;

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

(c) out of pocket expenses.

(3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

(a) the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

(b) the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).]

[F86 (3C) A UK notified body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

(a) a fee of £8,252 in respect of the application; and

(b) where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit.

(3D) Where the Secretary of State conducts an assessment of a UK notified body pursuant to article 5 of Regulation (EU) No 920/2013, the UK notified body shall pay to the Secretary of State—

(a) if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £2,586; or

(b) in any other case, a fee of £3,876.

(3E) A UK notified body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £532.]

(4) A fee under this regulation—

(a) in connection with an application for designation under [F87 regulation 45(1),] a variation under regulation 45(4)[F88 , a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012]—

(i) shall be payable when the application [F89 or submission] to the Secretary of State is made, and

(ii) shall accompany the application [F90 or submission] when it is made;

(b) in connection with an inspection pursuant to regulation 45(7) [F91 or an audit or assessment pursuant to Regulation (EU) No 920/2013], 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.

[F92 (5) In this regulation, “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.]

Extent Information

E6 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F75 Sum in reg. 54(1)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(2)(a)

F76 Sum in reg. 54(1)(b) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(2)(b)

F77 Sum in reg. 54(2) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(3)

F78 Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16

F79 Reg. 54(3)(a)-(c) substituted (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(2)(c)

F80 Sum in reg. 54(3)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(a)

F81 Sum in reg. 54(3)(b) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(b)

F82 Sum in reg. 54(3)(c) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(c)

F83 Reg. 54(3A)(3B) 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(2)(d)

F84 Sum in reg. 54(3A)(a)(i) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(5)(a)

F85 Sum in reg. 54(3A)(a)(ii) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(5)(b)

F86 Reg. 54(3C)-(3E) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(6)

F87 Words in reg. 54(4)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(i)

F88 Words in reg. 54(4)(a) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(ii)

F89 Words in reg. 54(4)(a)(i) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

F90 Words in reg. 54(4)(a)(ii) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

F91 Words in reg. 54(4)(b) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(b)

F92 Reg. 54(5) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(8)

F38 Fees payable in connection with the designation etc. of ... conformity assessment bodies E+W+S

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as [F39 a 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 [F40 £8,918]; or

(b) in all other cases, a fee of [F41 £35,672].

[F42 (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) [F43 Subject 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 [F44 a CAB] arising out of [F45 a mutual recognition agreement] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F46 (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 [F47 £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 [F48 £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 [F49 £1,880];

(d) in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F50 £10,072 ] plus the amounts specified in paragraph (3D).]

[F51 (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 [F52 £58,341] plus—

(a) [F53 £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 [F54 £10,072 ] plus—

(a) [F55 £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 [F56 £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 [F57 £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 [F58 £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

E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F38 Word 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)

F39 Words 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)

F40 Sum 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)

F41 Sum 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)

F42 Reg. 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)

F43 Words 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)

F44 Words 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)

F45 Words 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)

F46 Reg. 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)

F47 Sum 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)

F48 Sum 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)

F49 Sum 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)

F50 Sum 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)

F51 Reg. 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)

F52 Sum 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)

F53 Sums 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)

F54 Sum 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)

F55 Sums 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)

F56 Sum 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)

F57 Sum 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)

F58 Sum 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)

F93 Fees payable in connection with the designation etc. of ... conformity assessment bodies N.I.

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as [F94 a 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 [F95 £8,918]; or

(b) in all other cases, a fee of [F96 £35,672].

[F97 (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

(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) [F98 Subject 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 [F99 a CAB] arising out of [F100 a UK mutual recognition agreement] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F101 (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 [F102 £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 [F103 £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 [F104 £1,880];

(d) in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F105 £10,072] plus the amounts specified in paragraph (3D).]

[F106 (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 [F107 £58,341] plus—

(a) [F108 £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 [F109 £10,072] plus—

(a) [F110 £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 [F111 £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 [F112 £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 [F113 £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

E7 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F93 Word in reg. 55 heading omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(a)

F94 Words in reg. 55(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(b)

F95 Sum in reg. 55(1)(a) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(2)(a)

F96 Sum in reg. 55(1)(b) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(2)(b)

F97 Reg. 55(2) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(3)

F98 Words 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)

F99 Words in reg. 55(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(c)(i)

F100 Words in reg. 55(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(c)(ii)

F101 Reg. 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)

F102 Sum in reg. 55(3)(a) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(4)(a)

F103 Sum in reg. 55(3)(b) substituted N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(4)(b)

F104 Sum 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)

F105 Sum in reg. 55(3)(d) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(4)(b)

F106 Reg. 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)

F107 Sum in reg. 55(3A) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(5)

F108 Sums 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)

F109 Sum in reg. 55(3B) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(6)

F110 Sums 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)

F111 Sum 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)

F112 Sum in reg. 55(3D)(a)(i) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(7)(a)

F113 Sum in reg. 55(3D)(a)(ii) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(7)(b)

Fees payable in relation to clinical investigation notices E+W+S

56.—(1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

(a) if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

(i) a fee, if the device is a Group A device, of [F59 £5,711], or

(ii) a fee, if the device is a Group B device, of [F60 £11,069]; or

(b) in all other cases—

(i) a fee, if the device is a Group A device, of [F61 £7,472], or

(ii) a fee, if the device is a Group B device, of [F62 £15,627].

(2) Except where paragraph (3) [F63 or (3A)] applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or [F64 their UK responsible person] has previously given such notice in relation to that device.

(3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

(a) a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

(b) a change to the number of patients or devices forming the basis of the proposed trial;

(c) a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

(d) a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

(e) a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

[F65 (3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

(a) a fee, if the device is a Group A device, of £207; or

(b) a fee, if the device is a Group B device, of £331.]

[F66 (3B) A person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—

(a) £906 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and

(b) £782 for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b).]

(4) A fee under this regulation—

(a) shall be payable when the notice to which it relates is given to the Secretary of State; and

(b) shall accompany that notice when it is given.

Extent Information

E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F59 Sum in reg. 56(1)(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), 13(1)(a)

F60 Sum in reg. 56(1)(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), 13(1)(b)

F61 Sum in reg. 56(1)(b)(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), 13(1)(c)

F62 Sum in reg. 56(1)(b)(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), 13(1)(d)

F63 Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2)

F64 Words in reg. 56(2) 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(4A) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 49); 2020 c. 1, Sch. 5 para. 1(1)

F65 Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3)

F66 Reg. 56(3B) inserted (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), 13(2)

Fees payable in relation to clinical investigation notices N.I.

56.—(1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

(a) if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

(i) a fee, if the device is a Group A device, of [F114 £2,920], or

(ii) a fee, if the device is a Group B device, of [F114 £3,570]; or

(b) in all other cases—

(i) a fee, if the device is a Group A device, of [F115 £3,820], or

(ii) a fee, if the device is a Group B device, of [F115 £5,040].

(2) Except where paragraph (3) [F116 or (3A)] applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or his authorised representative has previously given such notice in relation to that device.

(3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

(a) a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

(b) a change to the number of patients or devices forming the basis of the proposed trial;

(c) a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

(d) a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

(e) a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

[F117 (3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

(a) a fee, if the device is a Group A device, of £207; or

(b) a fee, if the device is a Group B device, of £331.]

(4) A fee under this regulation—

(a) shall be payable when the notice to which it relates is given to the Secretary of State; and

(b) shall accompany that notice when it is given.

Extent Information

E8 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F114 Sums in reg. 56(1)(a) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(a)

F115 Sums in reg. 56(1)(b) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(b)

F116 Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2)

F117 Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3)

[F67 Fees in connection with approval of coronavirus test devices E+W+S

56A.— (1) A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—

(a) £14,000; or

(b) if the person is a small or medium-sized enterprise, £6,200.

(2) Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—

(a) a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or

(b) a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.

(3) In this regulation—

(a) a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and

(b) “persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.]

Textual Amendments

F67 Reg. 56A inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 9

[F68 Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device E+W+S

56B.— (1) Subject to paragraph (2), the fee payable by an approved body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulation 56C.

(2) No fee is payable if it is the first time the Secretary of State has been consulted by any approved body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.]

Textual Amendments

F68 Reg. 56B inserted (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), 14

[F69 Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device E+W+S

56C.— (1) Subject to regulation 56B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—

(a) £4,550 if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b) £10,604 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

(2) Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—

(a) £900 if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b) £2,451 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

(3) In relation to a device which incorporates a new medicinal substance, the fee is—

(a) £46,526 for a consultation; and

(b) £11,551 for a further consultation.

(4) Where an approved body consults the Secretary of State in relation to more than one device at the same time and those devices—

(a) are of similar construction and are designed to perform similar functions;

(b) incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

(c) do not incorporate any other medicinal substance;

the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.

(5) Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which an approved body consults the Secretary of State.]

Textual Amendments

F69 Reg. 56C inserted (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), 15

[F70 Fees payable in connection with pre-consultation meetings E+W+S

56D.— (1) The fee payable by a person other than an approved body with whom the Secretary of State holds a meeting in order to provide scientific advice with a view to that person making an application for an examination certificate in relation to a device incorporating a medicinal substance is specified in paragraph (3).

(2) The fee payable by an approved body with whom the Secretary of State holds a meeting in order to provide scientific advice with a view to that body consulting the Secretary of State in relation to an application for an examination certificate in relation to a device incorporating a medicinal substance is specified in paragraph (3).

(3) The fee payable is—

(a) £824, if the advice provided at that meeting consists of advice in connection with—

(i) quality development only, or

(ii) safety development only;

(b) £1,044, if the advice provided at that meeting consists of advice in connection with—

(i) quality and safety development only, or

(ii) clinical development only;

(c) £1,429, if the advice provided at that meeting consists of advice in connection with—

(i) quality and clinical development only, or

(ii) safety and clinical development only;

(d) £1,813, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.

(4) Any fee payable under this regulation must be paid within 14 days following written notice from the Secretary of State requiring payment of that fee ]

Textual Amendments

F70 Reg. 56D inserted (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), 16

Unpaid fees E+W+S

57.  All unpaid sums due by way of, or on account of, any fees payable under this Part are recoverable as debts due to the Crown.

Waivers, reductions and refunds E+W+S

58.—(1) The Secretary of State may—

(a) waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

(b) refund the whole or part of any fee paid pursuant to this Part.

(2) Without prejudice to the generality of paragraph (1), where—

(a) a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

(b) an application for designation as—

(i) [F71 an approved body] under regulation 45(1), or

(ii) [F72 a CAB] under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.

Textual Amendments

F71 Words in reg. 58(2)(b)(i) 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(5)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 50); 2020 c. 1, Sch. 5 para. 1(1)

F72 Words in reg. 58(2)(b)(ii) 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(5)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 50); 2020 c. 1, Sch. 5 para. 1(1)

Waivers, reductions and refunds N.I.

58.—(1) The Secretary of State may—

(a) waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

(b) refund the whole or part of any fee paid pursuant to this Part.

(2) Without prejudice to the generality of paragraph (1), where—

(a) a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

(b) an application for designation as—

(i) a notified body under regulation 45(1), or

(ii) [F118 a CAB] under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.

Textual Amendments

F118 Words in reg. 58(2)(b)(ii) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 22