UK Updates- MHRA Consultation on Fee Proposal for 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting stakeholders to provide feedback on its proposals to update statutory fees. This update aims to ensure that the MHRA continues to recover its costs in full, in alignment with HM Treasury's Managing Public Money guidelines. Regular updates to these fees are essential to maintain financial sustainability and to support the delivery of MHRA's services. If approved, the proposed changes will come into effect in April 2025.
Key Information Sought:
MHRA is seeking opinions on the following proposals:
- 1. Fee Increases
- 2. Medical Device Registration Fee Update- The existing fee will be amended to account for costs related to post-market activities for medical devices.
- 3. New Regulatory Advice Service- A new service will be introduced to provide regulatory advice meetings for medical devices.
- 4. Amendments to Existing Services- MHRA proposes fee increases and amendments to three services, as well as the removal of 51 fees that are no longer applicable.
- 5. Homeopathic Product Fees- The legal definition of a "standard variation" application for homeopathic products will be updated, though the associated statutory fee will remain unchanged.
Statutory fees, as detailed in the consultation document, will increase to ensure continued cost-recovery until 2027. This includes fees for:
Consultation Timeline
The new fee structure is expected to take effect in April 2025, and fees will be reviewed every two years thereafter. Stakeholders are invited to provide their feedback via the survey, which runs from August 29, 2024, until October 24, 2024, at 11:59 PM. You can access the consultation document and survey link here.
Implications for Medical Device Manufacturers
The consultation outlines two significant changes for medical device manufacturers:
- 1. Annual Registration Fee MHRA proposes a shift from a one-time registration fee to an annual maintenance fee of £210 per GMDN code to cover post-market activities. For manufacturers with numerous registered devices, costs could escalate significantly. For example, a company with 100 GMDN codes would be liable for £21,000 per year.
- 2. Regulatory Advice Meetings A new service will offer expert regulatory advice to manufacturers of complex or innovative medical devices. The proposed fee is £987 for a one-hour meeting, covering pre-meeting preparations, discussions, and post-meeting feedback.
Comparison to Existing Fees
| Service Type | Percentage Increase/Fee |
|---|---|
| Clinical Amendment/Consultation | 9.1% |
| Clinical Notification | 104.9% |
| Drug-Device Combination | 8.9% |
| Approved Body Designation and Monitoring | 15.9% |
| Registration | £210 annual fee per GMDN code |
| New Regulatory Advice Meetings | £987 per hour |
| Source: Association of British HealthTech Industries (ABHI) | |
International Comparisons
Compared to the US FDA and Ireland’s HPRA, MHRA’s proposed fee changes are substantially higher—up to 5 to 10 times greater. For example, surgical instrument manufacturers with over 150 GMDN codes could see their registration costs soar to £31,500 annually, compared to no annual fee under the current EUDAMED system.
Conclusion
The proposed fee changes are likely to impact a wide range of medical device manufacturers, particularly those with a large number of devices or lower-risk products. Stakeholders are encouraged to participate in the consultation to ensure their concerns are heard. If you have any questions or encounter issues with your consultation response, please contact info@sushvin.com
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market. If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
FAQ's
What is the MHRA Consultation on Statutory Fees About?
The MHRA is seeking feedback on proposals to update its statutory fees to ensure they can continue to cover the costs of their services. This consultation is open from 29 August 2024 to 24 October 2024.
The MHRA regularly revises its fees to align with HM Treasury’s “Managing Public Money” guidance, ensuring full cost-recovery. These updates are crucial for maintaining the long-term financial sustainability of the agency and ensuring the continued delivery of its services. The proposed fee changes are expected to take effect in April 2025.
