Open MHRA consultations
Finding open consultations
MHRA consultations are published on the UK Government consultations page: gov.uk/government/consultations — filter by MHRA
Consultations cover proposed changes to UK MDR 2002, new guidance, fee changes, and the reformed regulatory framework.
How to respond to consultations
- Navigate to the consultation on gov.uk
- Read the consultation document in full
- Prepare your response — typically a written submission addressing the specific questions posed
- Submit via the online portal or by email as directed
Industry trade associations (ABHI, BIVDA, and others) often coordinate joint consultation responses. Engaging with these bodies is an efficient way to contribute to consultations on shared industry concerns.
MHRA's reform consultations (2021–2022)
MHRA published major consultations on the future of UK medical device regulation in 2021 and 2022, covering:
- Proposed new framework structure
- Clinical evidence requirements
- UDI implementation
- Economic operator obligations
- IVD classification reform
MHRA's response to these consultations, and the implementation timeline, are expected to be communicated via further statutory instruments. Monitor this page for updates.
Official references
| Reference | Description |
|---|---|
| MHRA consultations | All open and closed MHRA consultations |
| MHRA: Future regulation of medical devices | 2021/2022 consultation response |