Explanatory note

These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”), the Blood Safety and Quality Regulations 2005 (“the 2005 Regulations”) and the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”).

The fee amounts in these Regulations represent increases in the majority of existing fees of between 9% and 16%, with some fees, primarily relating to clinical investigations, rising by more than this, and are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 29 August 2024. A summary of the consultation responses and the Government’s response to the consultation are published on the MHRA’s website (www.mhra.gov.uk).

Part 2 amends the 2002 Regulations. Regulations 3 and 4 increase existing fees payable to the Secretary of State in relation to the registration of devices. Regulations 5 to 7 increase existing fees payable to the Secretary of State in relation to the designation of approved bodies, UK notified bodies and conformity assessment bodies. Regulations 8 and 9 increase existing fees payable to the Secretary of State in relation to clinical investigation notices and consultations on the safety, quality and usefulness of a medicinal substance incorporated in a device. Regulation 11 introduces a new optional service provided by the Secretary of State, and corresponding fee, in relation to regulatory advice, and regulation 10 omits a fee replaced by the new service. Regulation 12 increases the time for payment by small companies of fees payable to the Secretary of State in relation to clinical investigations.

Part 3 amends the 2005 Regulations. Regulation 13 amends regulation 22 of the 2005 Regulations to increase the fees payable by blood establishments and hospital blood banks or facilities in relation to authorisation, operation and haemovigilance.

Part 4 amends the 2021 Regulations. Regulation 15 increases the existing fee in connection with the registration of custom-made devices. Regulation 16 increases the time for payment by small companies of fees payable to the Secretary of State in relation to clinical investigations. Regulations 17, 19 and 21 increase existing fees payable to the Secretary of State in connection with clinical investigations, advice in relation to intended clinical investigations and consultations on the safety, quality and usefulness of a medicinal substance incorporated in a device. Regulations 18 and 22 increase existing fees payable to the Secretary of State in connection with the designation of notified bodies. Regulation 20 omits a fee replaced by the new optional service provided by the Secretary of State in relation to regulatory advice introduced by regulation 11.

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.