MHRA Regulatory Advice Meetings: Updated Guidance for Medical Device Manufacturers
Published: 3 December 2025, the MHRA (UK's Medicines and Healthcare products Regulatory Agency) released updated guidance on how manufacturers can request regulatory advice meetings for medical devices and IVDs. This service offers an important opportunity to clarify UK regulatory expectations—but with strict boundaries and fees to consider.
Key Takeaways for Manufacturers
What it covers: Regulatory advice for medical devices and IVDs where existing guidance is unclear. The MHRA will not provide consultancy on specific device design or performance.
What it excludes:
Future regulation insights
Product-specific consultancy
Media or endorsement requests
Formal notified/approved body processes
Scope: Limited to Great Britain regulations only—MHRA does not offer advice on EU/NI device regulations.
How to Request a Meeting
To apply, manufacturers must complete an online form available here and submit relevant background information and specific questions. Supporting documentation should be sent to devices.regulatoryadvice@mhra.gov.uk with a reference number.
Expectations:
The MHRA will propose a meeting date within 15 days.
Meetings are typically scheduled after full payment of the £987 fee, which must be paid at least 3 weeks in advance.
Meetings last up to 1 hour, beginning with a 10–15 minute presentation by the applicant.
After the Meeting
Applicants are responsible for taking and submitting meeting notes within 15 working days. MHRA will review and return the notes within 30 days. Clarification requests are possible but must not include new questions—additional queries will be charged as a new request.
Why This Matters
For UK-market device manufacturers, this advisory service can help de-risk complex regulatory questions early in development or before formal submission. However, manufacturers should be strategic—this service is best used when navigating unclear guidance, not general consultation.
Read the full document below.
