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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.Ìý

The MHRAÌýruns separate advisory services forÌýclinical investigationsÌý²¹²Ô»åÌýscientific advice for medicines.ÌýYou may alsoÌýwish to reach out to theÌýInnovation OfficeÌýfor 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. See other relevant points of contactÌýat Contact MHRA.

What is this service for?

This serviceÌýprovidesÌýregulatory adviceÌýmeetings relating to medical devices, particularly where the application ofÌýexisting regulatory guidance is not straightforward.ÌýÌý

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

This service is notÌýintended to be a substitute for, replace, or constitute the formal process of structured dialogue carried out by an approved body.Ìý

In addition, this service cannot provide the following:Ìý

• Insights intoÌýthe development of future medical device regulations, Ìý

• Request for feedback or support from an approved body, Ìý

• Answers to mediaÌýor newsÌýenquiriesÌý

• Long-term collaboration, Ìý

• PromotionÌýor 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 or development of a medical/IVD device that the MHRA or an Approved Body will use to make an assessment decision.

How toÌýrequest a regulatory advice meetingÌý

Before youÌýsubmitÌýyour request, pleaseÌýensure you have reviewedÌýthe relevantÌýMHRAÌýguidance.ÌýThe MHRA has published a range of guidance, including on:Ìý

• Regulating medical devices in the UKÌý

• How to register your medical devices with the MHRAÌý

• Borderline products: classifying medical devices and riskÌý

• Clinical investigations for medical devicesÌý

• Medical devices: software applicationsÌý

• In vitro diagnostic medical devices: guidance on legislation

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

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

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

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

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.Ìý

FeesÌý

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

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

Fees for regulatory advice. Ìý

During the meetingÌý

Meetings will beÌýlimitedÌýto one hourÌýand start with aÌýshort presentation (10 to 15 minutes) by the person or organisation asking for advice. This presentationÌýshouldÌýdeliver an overview of the issues or controversies surrounding their questions.ÌýPlease send any presentation slides toÌýdevices.regulatoryadvice@mhra.gov.ukÌýat least two weeks before the agreed meeting date.Ìý

It will be yourÌýresponsibility 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.ÌýÌý

After the meetingÌý

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.Ìý

If you need clarification on the advice provided, you can ask us byÌýemail atÌýdevices.regulatoryadvice@mhra.gov.uk. Please quote your reference number.   Ìý

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

Limitations of MHRA adviceÌý

The MHRA works hard to provide useful,ÌýaccurateÌýand expert advice.  ÌýÌýÌý

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

ComplaintsÌý

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

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