UK MHRA Guidance: Getting Regulatory Advice for Medical Devices

If you're developing a medical device or in vitro diagnostic (IVD) and need clarity on UK regulatory requirements, the MHRA offers a dedicated paid advisory meeting service. This guidance, "Medical devices: get regulatory advice from the MHRA" is particularly useful when the application of existing regulations to your specific device or situation isn't straightforward. Here's a full breakdown of how the service works.

What it's for

The service is designed to provide regulatory advice on medical devices and IVDs where existing published guidance doesn't give a clear enough answer for your specific circumstances. Before submitting a request, you should review all applicable MHRA guidance — if your questions are already addressed there, the MHRA will direct you to that guidance rather than offering a meeting.

It's important to understand what this service does not cover. It is not a substitute for the formal structured dialogue process carried out by an Approved Body, and the MHRA will not provide product-specific consultancy covering design, development, verification, validation or manufacture. The service also cannot offer insights into future regulatory developments, provide Approved Body feedback, respond to media enquiries, or offer long-term collaboration or MHRA endorsement. For general medical device enquiries, contact info@mhra.gov.uk or visit the MHRA contact page.

How to apply

Submit your request using the MHRA's online form, which asks for relevant background information and a list of specific questions you'd like advice on. If you prefer to prepare your answers in advance, a PDF version of the form is available to download from GOV.UK. You won't need to complete every section — the electronic form will skip parts that don't apply to your enquiry. Any supporting documents should be emailed to devices.regulatoryadvice@mhra.gov.uk, quoting your reference number.

Once submitted, the MHRA will acknowledge your application and propose a meeting date and time within 15 days. The actual lead time to your meeting will depend on the subject matter and the internal expertise required, so it's strongly encouraged to plan and apply early. Prior to the meeting, the MHRA may also request additional information to clarify your submission — delays in responding to these requests may push back your meeting date.

Cost

The fee is £987 per meeting. Once your request is accepted, you'll receive a payment link. Payment must be completed at least 3 weeks before your meeting date, or the meeting may be delayed.

The meeting

Meetings are limited to one hour. You will open with a short presentation of 10 to 15 minutes, providing an overview of the issues or controversies around your questions. Slides should be sent to devices.regulatoryadvice@mhra.gov.uk at least two weeks before the agreed meeting date. You are responsible for taking notes throughout the meeting. MHRA experts will then review your notes for accuracy after the meeting at no additional cost.

After the meeting

Send your meeting notes to the MHRA within 15 working days of the meeting. They will review and return them within 30 days, noting any corrections or changes and the reasons for them. If you need clarification on the advice provided, you can follow up by email quoting your reference number. However, you should not use this as an opportunity to expand the scope of the original advice or raise new questions based on what was discussed — if you do, the additional advice will be charged at the same rate as the original meeting.

Key limitations

All advice provided by the MHRA is given without prejudice. This means it does not override any legal requirements relating to the approval and placement of medical devices on the UK market, and it does not affect any intellectual property rights belonging to third parties. The service covers Great Britain regulations only — it does not extend to EU medical device regulations applicable in Northern Ireland.

Complaints

If you wish to raise a complaint about the process, email MHRACustomerServices@mhra.gov.uk with a full summary of your complaint and any supporting information you consider relevant.

Source: Medical devices: get regulatory advice from the MHRA (updated December 2025)