During the consultation that ended on 23rd November, MHRA submitted proposals to change the mandatory registration fees for Medical Devices that would apply from 1st April 2023.

Three adjustments were proposed, which are detailed below:

  • 10% increase in indexation for the Agency’s mandatory fees. The indexation is linked to staff costs increased by 10% since the last fee review in 2016. The proposed list of fees, reflecting the 10% increase in indexation, can be found in Annex B – MHRA statutory fee proposals (table 1);
  • additional increase of 61 fees for services requiring cost recovery. The increase in each fee varies according to the cost of the activity, tasks and workload required to provide the service. The list of fees affected by this cost-based increase can be found in Annex B – MHRA statutory fee proposals (table 2);
  • Introduction of 22 new fees to ensure that the Agency adequately recovers the costs of regulatory activity across all of its services, in line with HM Treasury’s principles on managing public money, following the last fee changes in 2016/2017 for Medicines and 2017/2018 for Medical Devices. Fees for these services will be kept under review over the next 12 months and, if necessary, adjusted in April 2024 to ensure they are as close to cost recovery as possible. The list of the 22 proposed new fees can be found in Annex B – MHRA statutory fee proposals (table 3).

The fees are expected to come into effect in April 2023 and cost recovery will be monitored for the first year after implementation to ensure that the new fees cover actual costs.

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Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1101660/MHRA-Statutory-Fees-Consultation.pdf