The Medical Devices (Fees Amendment) Regulations 2026

• Citation: S.I. 2026/197
• Sections: 5

Section 1 Citation, commencement, extent and application

(1) These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2026.

(2) These Regulations come into force on 1st April 2026.

(3) Any amendment made by these Regulations has the same extent and application as the provision amended, subject to paragraph (4).

(4) In these Regulations—

(a) regulation 3 applies in relation to England and Wales and Scotland;

(b) regulation 4 applies in relation to Northern Ireland.

Section 2 Amendment of the Medical Devices Regulations 2002

The Medical Devices Regulations 2002 are amended in accordance with regulations 3 and 4.

Section 3 Amendment of regulation 53 in relation to England and Wales and Scotland

In regulation 53 (fees in connection with the registration of devices and changes to registration details) —

(a) the existing text becomes paragraph (1);

(b) in that paragraph, for “£261” substitute “£300” ;

(c) after that paragraph, insert—

(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—

holding information supplied in relation to a registration;

regulatory oversight by the Secretary of State;

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 Level 2 Category; or

where there is no applicable category under sub-paragraph (a), a Level 1 Category.

Section 4 Amendment of regulation 53 in relation to Northern Ireland

In regulation 53 (fees in connection with the registration of devices and changes to registration details) —

(a) the existing text becomes paragraph (1);

(b) in that paragraph, for “£261” substitute “£300” ;

(c) after that paragraph, insert—

(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—

holding information supplied in relation to a registration;

regulatory oversight by the Secretary of State;

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 Level 2 Category; or

where there is no applicable category under sub-paragraph (a), a Level 1 Category.

Section 5 Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021

(1) The Medical Devices (Northern Ireland Protocol) Regulations 2021 are amended as follows.

(2) In regulation 7 (registration of custom-made devices) —

(a) in paragraph (5), for “£261” substitute “£300” ;

(b) after paragraph (5), insert—

(5A) Any person who has a registration in accordance with this regulation 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 (5); and

(b) shall be due on the first day of each fee period in relation to which a fee is payable.

(5B) 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).

(5C) Where a person registers a device under this regulation after the first day of a fee period, then the amount of the fee due in accordance with paragraph (5) 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.

(5D) 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.

(5E) 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 (5A) begins on 1st April 2026 and ends on 31st March 2027.

(5F) 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—

holding information supplied in relation to a registration;

regulatory oversight by the Secretary of State;

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 Level 2 Category; or

where there is no applicable category under sub-paragraph (a), a Level 1 Category.