DHSC has launched a request for stakeholder input as part of its statutory report under the Medicines and Medical Devices Act 2021. This report assesses how the regulations made under the Act are operating in practice.
BIVDA has been invited to coordinate a sector response, and the UKCA Subgroup will be used to collate industry views where possible.
We are seeking input from members on the regulations in scope and how they are functioning in practice, including any:
- Operational challenges or unintended consequences
- Areas where regulations are working well
- Suggested improvements or clarifications
- Broader policy or regulatory concerns relevant to UKCA / medical devices regulation
The DHSC deadline for submission is 12 June 2026, so we will need to close the BIVDA internal feedback process on 22nd May 2026 to allow time for consolidation.
To help structure the response, we will circulate a short survey covering:
- Positive aspects of the regulations
- Key issues experienced in practice
- Priority areas for change or clarification
- Any additional narrative comments
If you would like to contribute personally or as a consolidated response on behalf of your organisation, please complete the survey using the link here.
We encourage participation even if your feedback is brief, as this will help ensure a balanced and representative industry view.
