Interpretation of Part VI
(1) In this Part ...—
“ approved manufacturer ” in relation to a medicinal substance means a manufacturer who—
holds a manufacturing authorisation which permits the manufacturer to manufacture that substance for inclusion in an authorised medicinal product; or
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;
“ authorised medicinal product ” means a medicinal product in respect of which a marketing authorisation has been granted;
“ clinical development ” means the conduct of studies of a medicinal substance in human subjects in order to—
discover or verify the effects of such a substance,
identify any adverse reaction to such a substance, or
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;
“ consultation ” means a consultation required by—
section 4.3 of Annex II of Directive 93/42 or Directive 90/385; or
section 5 of Annex III of Directive 93/42 or Directive 90/385;
“ examination certificate ” means—
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;
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;
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
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;
“ further consultation ” means a consultation by an approved body in relation to any device which—
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;
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
is of a similar design or type to a device which has been the subject of an unsuccessful application for an examination certificate where—
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
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.
“ incorporates ” means incorporates as an integral part;
“ marketing authorisation ” has the meaning given by regulation 8 of the Human Medicines Regulations 2012;
“ 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;
“ new medicinal substance ” means a medicinal substance which is not—
an authorised medicinal product;
an ingredient or, as the case may be, the sole active ingredient of such a product; or
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;
“ 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;
“ 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;
“ 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
“ 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.
Fees in connection with the registration of devices and changes to registration details
Any person required to supply the Secretary of State with any information under 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 £261 , 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.
Fees payable in connection with the designation of approved bodies
(1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as 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 £10,335 ; or
(b) in all other cases, a fee of £41,337 .
(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 £14,568 ;
(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 £21,105 .
(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, 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 a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—
(a) in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of £67,606 plus the amounts specified in paragraph (3A);
(b) in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of £52,929 , plus the amounts specified in paragraph (3A); and
(c) in respect of an inspection pursuant to regulation 45(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3A).
(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 £732 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 £198 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).
(3C) 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 £41,337 in respect of the application; and
(b) where an audit is carried out in connection with the application, a fee of £67,606 in respect of the audit ,
plus the amounts specified in paragraph (3A).
(3D) Where the Secretary of State conducts an assessment of an approved body pursuant to article 5 of Regulation ( EU ) No 920/2013, 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 £21,535 ; or
(b) in any other case, a fee of £26,408 ,
plus the amounts specified in paragraph (3A).
(3E) 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 £1,503 .
(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 £26,408 , 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 regulation 45(1), a variation under regulation 45(4) , 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 or submission to the Secretary of State is made, and
(ii) shall accompany the application or submission when it is made;
(b) in connection with an inspection pursuant to regulation 45(7) 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.
(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.
Fees payable in connection with the designation etc. of ... conformity assessment bodies
(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as 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 £10,335 ; or
(b) in all other cases, a fee of £41,337 .
(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 £14,568 ; 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 £21,105 .
(3) 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 a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—
(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 £67,606 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 £11,672 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 £1,880 ;
(d) in respect of an inspection pursuant to regulation 48(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3D).
(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 £67,606 plus—
(a) £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 £11,672 plus—
(a) £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 £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 £732 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 £198 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.
Fees payable in relation to clinical investigation notices
(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 £11,701 , or
(ii) a fee, if the device is a Group B device, of £22,678 ; or
(b) in all other cases—
(i) a fee, if the device is a Group A device, of £15,309 , or
(ii) a fee, if the device is a Group B device, of £32,016 .
(2) Except where paragraph (3) 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 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.
(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 £226 ; or
(b) a fee, if the device is a Group B device, of £361 .
(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) £987 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and
(b) £852 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.
Fees in connection with approval of coronavirus test devices
(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.
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
(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.
Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
(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) £4,953 if each medicinal substance is manufactured by an approved manufacturer of that substance;
(b) £11,543 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) £980 if each medicinal substance is manufactured by an approved manufacturer of that substance;
(b) £2,668 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) £50,644 for a consultation; and
(b) £12,574 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.
Fees payable in connection with pre-consultation meetings
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Fees payable in connection with regulatory advice meetings
(1) Unless regulation 56(3B)(a) applies, or regulation 17A(2)(a) of the Medical Devices (Northern Ireland Protocol) Regulations 2021 applies, the fee payable by a person with whom the Secretary of State holds a meeting in order to provide regulatory advice relating to a medical device is £987 for each hour that meeting takes.
(2) 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.
Unpaid fees
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
(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) an approved body under regulation 45(1), or
(ii) 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.
Time for payment of fees - small companies
(1) Where a fee in regulation 56(1) is payable by a small company, if the small company so requests to the Secretary of State in writing, 50% of that fee shall be payable when the notice to which it relates is given to the Secretary of State and 50% of that fee shall be payable within six months of the date when the notice is given.
(2) For the purpose of this regulation, a company is a small company if, for the financial year before that in which the notice is given, the total value of products it has sold or supplied for the financial year is not more than the amount specified in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006 and either—
(a) the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount specified in item 2 in section 382(3) of that Act; or
(b) the average number of persons employed by the company in the financial year before that in which the notice is given (determined on a weekly basis) does not exceed the number specified in item 3 in section 382(3) of that Act.
(3) In this regulation, a reference to section 382 of the Companies Act 2006 is a reference to that section as amended by the Companies (Accounts and Reports) (Amendment and Transitional Provision) Regulations 2024.
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