Regulatory advice is offered by the MHRA on regulations and procedures for medical devices and in vitro diagnostic (IVD) devices. You can request a meeting by completing a request form.

The MHRA runs separate advisory services for clinical investigations and scientific advice for medicines. You may also wish to reach out to the Innovation Office for advice.

Note: General queries relating to medical devices, including software and AI as a medical device classification questions, should be directed to info@mhra.gov.uk. You can also find other relevant points of contact here.

What is this service for?

This service provides regulatory advice meetings relating to medical devices, particularly where the application of existing regulatory guidance is not straightforward.

It is highly encouraged that you review all applicable published guidance before requesting a meeting. If your questions are covered in existing guidance, we will direct you to that guidance rather than offering you a meeting.

This service is not intended to be a substitute for, replace, or constitute the formal process of structured dialogue carried out by an approved body.

In addition, this service cannot provide the following:

Insights into the development of future medical device regulations, 
Request for feedback or support from an approved body, 
Answers to media or news enquiries
Long-term collaboration, 
Promotion or endorsement from the MHRA,
A determination on whether your organisation qualifies as a health institution (though we can provide general advice on the health institution exemption and how it applies to your products),

Please note that the MHRA cannot provide consultancy services. This means that the MHRA can advise on how the regulations apply to your product but cannot provide tailored advice on the design, development, verification, validation and/or manufacture of a medical/IVD device that the MHRA or an Approved Body will use to make an assessment decision. The MHRA can also only advise on medical devices regulation requirements in Great Britain, not those that apply in Northern Ireland under EU regulations.

How to request a regulatory advice meeting

Before you submit your request, please ensure you have reviewed the relevant MHRA guidance. The MHRA has published a range of guidance, including on:

Submit a request by completing a request form. The form will ask for relevant background information, including a list of questions you would like advice on. Please send any other supporting documents to devices.regulatoryadvice@mhra.gov.uk, quoting your reference number.

You may wish to gather the information necessary to complete the form in advance. You can download a PDF version of the form here (PDF, 212 KB, 6 pages). Depending on your enquiry, you may not need to complete all sections of the form. The electronic form will skip sections that you are not required to complete.

The MHRA will acknowledge your application request following submission. The MHRA will then propose a meeting date and time within 15 days.

The time to a meeting will be reliant on the subject matter and expertise needed. It is encouraged to plan early.

Before the meeting, the MHRA may send a request for information to clarify your request. Delays to responses to information requests may delay the meeting.

Fees

When your request for a regulatory advice meeting is accepted by the MHRA, you will receive a link to pay. The fee is £987 for a meeting.

You need to pay at least 2 weeks before your meeting date, or your meeting may be delayed.

Fees for regulatory advice. 

During the meeting

Meetings will be limited to one hour and start with a short presentation (10 to 15 minutes) by the person or organisation asking for advice. This presentation should deliver an overview of the issues or controversies surrounding their questions. Please send any presentation slides to devices.regulatoryadvice@mhra.gov.uk at least two weeks before the agreed meeting date.

It will be your responsibility to take notes during the meeting, and MHRA experts will review your notes for accuracy at no extra cost after the meeting has taken place.

After the meeting

You should send us your meeting notes within 15 working days of the meeting taking place. We will review them for accuracy and return them within 30 days following receipt, outlining any corrections or changes and our reasons for them.

If you need clarification on the advice provided, you can ask us by email at devices.regulatoryadvice@mhra.gov.uk. Please quote your reference number.   

When asking for clarifications you should not expand the scope of the original advice sought or ask new questions based on the advice given. If you do, this additional advice will be charged at the same rate as the original meeting.  

Limitations of MHRA advice

The MHRA works hard to provide useful, accurate and expert advice.  

However, the advice provided is given without prejudice to any of MHRA’s regulatory or enforcement powers under the Medicines and Medical Devices Act 2021 and UK MDR 2002, or for the need to comply with any applicable legislation and MHRA guidance. The MHRA cannot provide legal advice, and you are advised to seek your own independent advice on legal issues.

Complaints

Applicants who wish to complain about the process should email info@mhra.gov.uk.

You must include a full summary of the complaint and any supporting information you consider relevant.

Medical devices: ask for a regulatory advice meeting from the MHRA