Medical devices: get regulatory advice from the MHRA
Source: gov.uk (2025-12-03)

How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.

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 meeting request form (https://forms.office.com/Pages/ResponsePage.aspx?id=XOon5Vhi0kyif4vSN-xMJvtW-XL9PFVHlxgjpwjlokhUQ0RRQlROMjFXWUNOR0xVWFRQUUZKSUw3Mi4u).

The MHRA runs separate advisory services for clinical investigations (https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device) and scientific advice for medicines (https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra).

The purpose of this service

This service provides regulatory advice 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.

Please note that the MHRA cannot provide consultancy on a specific product. Consultancy means providing product specific information about the design, development, verification, validation and manufacture of a medical device/IVD device that the MHRA or Approved Body will use to make an assessment decision. MHRA can only advise on medical devices regulation requirements in GB, not those that apply in NI under EU medical devices regulations.

How to request a regulatory advice meeting

Submit a request by completing a request form (https://forms.office.com/Pages/ResponsePage.aspx?id=XOon5Vhi0kyif4vSN-xMJvtW-XL9PFVHlxgjpwjlokhUQ0RRQlROMjFXWUNOR0xVWFRQUUZKSUw3Mi4u). 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 xxx@xxx.xx (mailto:xxx@xxx.xx), 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 ‘Ask for regulatory advice for medical devices’ (https://assets.publishing.service.gov.uk/media/692edd072a37784b16ecf863/Ask_for_regulatory_advice.pdf). 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 3 weeks before your meeting date, or your meeting may be delayed.

Fees for regulatory advice (https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees#devices-regulatory-advice-meeting).

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 xxx@xxx.xx (mailto:xxx@xxx.xx) 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 xxx@xxx.xx (mailto:xxx@xxx.xx). 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. This means it does not override any laws about the details and documents needed for medical devices to be approved and placed on the UK market. It also does not affect any intellectual property rights that belong to third parties.

Complaints

Applicants who wish to complain about the process should email xxx@xxx.xx (mailto:xxx@xxx.xx).

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