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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART VI
- Regulation 53
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The Medical Devices Regulations 2002, Section 53 is up to date with all changes known to be in force on or before 10 August 2026. 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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Fees in connection with the registration of devices and changes to registration detailsE+W+S
53.—[F1(1)] Any person required to supply the Secretary of State with any information under [F2regulation 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 [F3£300], 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.
[F4(2) Any person who has a registration in accordance with regulation 7A, 19, 21A, 33A or 44 shall, in respect of the maintenance of that registration by the Secretary of State, pay to the Secretary of State an annual fee of £300 for each device registered and that fee—
(a)shall be payable for each fee period during which the registration is maintained, starting with the fee period immediately following that in which the person paid the fee for the device registration in accordance with paragraph (1); and
(b)shall be due on the first day of each fee period in relation to which a fee is payable.
(3) Where a person is liable to pay a fee under this regulation in respect of a device, no fee is payable under this regulation for an additional device which has the same registration category (whether registered simultaneously or subsequently, and whether the additional device also has other registration categories or not).
(4) Where a person supplies information referred to in paragraph (1) after the first day of a fee period, then the amount of the fee due in accordance with paragraph (1) shall be adjusted, pro rata, starting with the day on which the information is supplied, in accordance with the remaining number of days in the fee period.
(5) A person may not place a device on the market unless they have paid all fees for which they are liable under this regulation, whether or not those fees relate to that device.
(6) Where a person has registered a device under this regulation prior to 1st April 2026, the first fee period for which a fee is payable under paragraph (2) begins on 1st April 2026 and ends on 31st March 2027.
(7) In this regulation—
“fee period” means the period beginning with 1st April in any year and ending with 31st March in the following year;
“Global Medical Device Nomenclature” means the standard for the naming and categorisation of medical devices as maintained by the GMDN Agency, a company with registered company number 05392271, or any successor to that company;
“maintenance”, in relation to a registration, includes—
(a)
holding information supplied in relation to a registration;
(b)
regulatory oversight by the Secretary of State;
(c)
monitoring, identification, and addressing of safety issues by the Secretary of State in relation to the device registered.
“registration category” means, in accordance with the Global Medical Device Nomenclature as at the first day of the relevant fee period—
(a)
a Level 2 Category; or
(b)
where there is no applicable category under sub-paragraph (a), a Level 1 Category.]
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
F1Reg. 53 renumbered as reg. 53(1) (E.W.S.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 3(a)
F2Words 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)
F3Sum in reg. 53(1) substituted (E.W.S.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 3(b)
F4Reg. 53(2)-(7) inserted (E.W.S.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 3(c)
Fees in connection with the registration of devices and changes to registration detailsN.I.
53.—[F5(1)] Any person required to supply the Secretary of State with any information under regulation 19 [F6, 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 [F7£300], 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.
[F8(2) Any person who has a registration in accordance with regulation 19, 21B, or 44 shall, in respect of the maintenance of that registration by the Secretary of State, pay to the Secretary of State an annual fee of £300 for each device registered and that fee—
(a)shall be payable for each fee period during which the registration is maintained, starting with the fee period immediately following that in which the person paid the fee for the device registration in accordance with paragraph (1); and
(b)shall be due on the first day of each fee period in relation to which a fee is payable.
(3) Where a person is liable to pay a fee under this regulation in respect of a device, no fee is payable under this regulation for an additional device which has the same registration category (whether registered simultaneously or subsequently, and whether the additional device also has other applicable registration categories or not).
(4) Where a person supplies information referred to in paragraph (1) after the first day of a fee period, then the amount of the fee due in accordance with paragraph (1) shall be adjusted, pro rata, starting with the day on which the information is supplied, in accordance with the remaining number of days in the fee period.
(5) A person may not place a device on the market unless they have paid all fees for which they are liable under this regulation, whether or not those fees relate to that device.
(6) Where a person has registered a device under this regulation prior to 1st April 2026, the first fee period for which a fee is payable under paragraph (2) begins on 1st April 2026 and ends on 31st March 2027.
(7) In this regulation—
“fee period” means the period beginning with 1st April in any year and ending with 31st March in the following year;
“Global Medical Device Nomenclature” means the standard for the naming and categorisation of medical devices as maintained by the GMDN Agency, a company with registered company number 05392271, or any successor to that company;
“maintenance”, in relation to a registration, includes—
(a)
holding information supplied in relation to a registration;
(b)
regulatory oversight by the Secretary of State;
(c)
monitoring, identification, and addressing of safety issues by the Secretary of State in relation to the device registered.
“registration category” means, in accordance with the Global Medical Device Nomenclature as at the first day of the relevant fee period—
(a)
a Level 2 Category; or
(b)
where there is no applicable category under sub-paragraph (a), a Level 1 Category.]
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F5Reg. 53 renumbered as reg. 53(1) (N.I.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 4(a)
F6Word 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
F7Sum in reg. 53(1) substituted (N.I.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 4(b)
F8Reg. 53(2)-(7) inserted (N.I.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 4(c)
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