September 9, 2024
By Karen Hill
On August 29,2024, the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a consultation to seek views from interested stakeholders on proposals (Proposal 1-5) to update its statutory fees. The aim is to recover expenses to achieve long-term financial sustainability and the ongoing delivery of the MHRA’s services. This full cost recovery approach also means that the regulated bear the cost of regulation, and government bodies do not profit from statutory fees or operate at a loss, which must be subsidized by the government and ultimately the taxpayer, including patients themselves.
Cost implications for medical device manufacturers, most significant (Proposal 2)
Proposal 2 intends to amend the existing Medical Device Registration fee to include the costs for medical device post-market activity. Currently the Department for Health and Social Care (DHSC) funds (grant) the monitoring by MHRA from the point at which a product is placed on the market to the end of the life cycle. The MHRA now wishes to charge manufacturers who benefit from the post-market work.
Manufacturers must already register their medical device products with the MHRA, with the current fee being £240 per registration application. The proposed new Medical Device Registration Fee will be £210 per GMDN registration. There will also be the introduction of an annual fee (at the same amount) for each of the GMDN categories under which a manufacturer registers their products.
The proposal intends to distribute the cost of providing a stable and supportive regulatory environment more equitably across market participants and therefore support competition, with 44% of suppliers currently registered only having one GMDN category registered.
Increases to existing statutory fees (Proposal 1)
In addition, under Proposal 1 which relates to proposed increases to existing statutory fees, it is proposed that the fees related to medical devices clinical investigations are also increased. The fees to notify of a clinical investigation would double.
|
Fee name |
Current |
Proposed |
|
9. Clinical investigations for devices: fees – Amendment fees – High risk device amendment |
£331 |
£361 |
|
9. Clinical investigations for devices: fees – Amendment fees – Low risk device amendment |
£207 |
£226 |
|
9. Clinical investigations for devices: fees – Consultation – Clinical Investigations statistical review |
£782 |
£852 |
|
9. Clinical investigations for devices: fees – Consultation – Device Regulatory Advice meeting |
£906 |
£987 |
|
9. Clinical investigations for devices: fees – Notification of a clinical investigation – Class I, IIa, or IIb other than implantable or long-term invasive devices (Resubmission) |
£5,711 |
£11,701 |
|
9. Clinical investigations for devices: fees – Notification of a clinical investigation – Class I, IIa, or IIb other than implantable or long-term invasive devices (Initial submission) |
£7,472 |
£15,309 |
|
9. Clinical investigations for devices: fees – Notification of a clinical investigation – Class IIb implantable or long-term invasive, Class III, and active implantable devices (Resubmission) |
£11,069 |
£22,678 |
|
9. Clinical investigations for devices: fees – Notification of a clinical investigation – Class IIb implantable or long-term invasive, Class III, and active implantable devices (Initial submission) |
£15,627 |
£32,016 |
Introduction of a new service providing regulatory advice meetings for medical devices (Proposal 3)
Proposal 3 relates to a new service to provide regulatory advice meetings to support manufacturers in understanding the application of the UK’s regulatory framework to their product(s). This service will be targeted particularly to those developing novel and/or complex products with the potential to significantly improve patient outcomes. The proposed cost of this service is £987 for a one-hour meeting.
MHRA consultation procedure and timeline
Responses to the consultation can be submitted online.
The consultation is now open and closes on Thursday, October 24. The implementation date for these proposed changes is April 2025 and they will remain in place until March 2027, when the next fee upload is planned.
Concluding remarks
Manufacturers with medical devices on the GB market, or who are planning to introduce new medical devices to that market, will need to take these new costs into consideration, especially if they market a high number of different device types or are considering conducting a clinical investigation.
If you would like your opinions to be considered, submit your responses before the end of October deadline.
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