UK MHRA Med Dev Guidance: MHRA Regulatory Advice Meetings for Medical Devices

To support industry stakeholders, the UK Medicines and Healthcare products Regulatory Agency (MHRA) offers a dedicated Regulatory Advice Meeting service for medical devices and in vitro diagnostic devices (IVDs). This service helps organisations better understand regulatory expectations, clarify complex requirements, and navigate the UK regulatory system more effectively.

The MHRA guidance titled “Medical devices: get regulatory advice from the MHRA” explains how manufacturers, developers, innovators, and regulatory professionals can request formal regulatory advice meetings with the agency.

The guidance applies to:

• Medical devices

• In vitro diagnostic devices (IVDs)

• Software as a Medical Device (SaMD)

• AI-based medical technologies

• Innovative or novel healthcare technologies

The service is particularly useful when existing guidance does not clearly address a specific regulatory question or when a product involves complex regulatory pathways.

The service aims to:

• Clarify regulatory expectations

• Support manufacturers developing innovative technologies

• Reduce regulatory uncertainty

• Improve application quality

• Help applicants understand UK regulatory pathways

• Facilitate early regulatory engagement

The MHRA strongly encourages applicants to review existing published guidance before requesting a meeting. If the questions are already addressed in publicly available guidance, the agency may redirect applicants to those resources instead of scheduling a meeting.

Who Can Request a Regulatory Advice Meeting?

The service is available to a wide range of stakeholders involved in medical device development and regulation, including:

• Medical device manufacturers

• IVD manufacturers

• Startups and innovators

• Regulatory consultants

• Academic institutions

• Digital health developers

• AI medical technology companies

• International manufacturers seeking UK market access

The service supports both UK-based and overseas organisations interested in placing devices on the Great Britain market.

Types of Topics Commonly Discussed

Regulatory advice meetings may cover various regulatory and procedural issues, including:

• Device classification

• UKCA and CE marking requirements

• Clinical evidence expectations

• Software and AI device regulation

• Post-market surveillance obligations

• Registration requirements

• Technical documentation expectations

• Conformity assessment pathways

• Borderline product questions

• Novel technology regulatory strategies

For AI and software-based products, the MHRA has highlighted ongoing reforms and lifecycle-focused regulatory approaches, making early regulatory engagement particularly valuable.

Topics Outside the Scope of the Service

The MHRA clearly explains that the service has limitations and is not intended to replace formal regulatory assessment processes. The agency cannot provide:

• Consultancy for specific product development

• Product design recommendations

• Validation or verification support

• Promotion or endorsement

• Long-term collaboration arrangements

• Insights into future unpublished regulations

• Approved body feedback services

• Media or news responses

Importantly, the MHRA emphasises that it can advise only on Great Britain medical device regulations and not on Northern Ireland requirements governed under EU legislation.

How to Request a Regulatory Advice Meeting

Applicants must complete the official MHRA request form for regulatory advice meetings. The form requests information such as:

• Company details

• Product description

• Device classification

• Specific regulatory questions

• Proposed discussion topics

• Background information and supporting documents

Fees for Regulatory Advice Meetings

The MHRA charges fees for regulatory advice meetings. The exact fee depends on the complexity, duration, and type of advice requested.

After submission, applicants are generally provided with cost information and meeting arrangements. The MHRA may invoice organisations following the meeting process.

What Happens During the Meeting?

Regulatory advice meetings usually involve MHRA regulatory experts and representatives from the applicant organisation.

During the meeting:

• Applicants present their product and regulatory questions

• The MHRA discusses relevant regulatory expectations

• Clarifications are provided on applicable guidance and processes

• Potential regulatory risks or challenges may be highlighted

Meetings are designed to facilitate constructive scientific and regulatory discussion rather than provide formal approvals or certifications.

After the Meeting

Following the meeting, the MHRA may provide written summaries or key discussion points depending on the type of meeting conducted.

Applicants are expected to use the feedback to support:

• Regulatory planning

• Technical documentation preparation

• Clinical evidence strategies

• UK market access activities

• Compliance planning

However, the advice provided is non-binding and does not guarantee future approval outcomes.

For more details, click the link below

• Ask for the regulatory advice meeting form (PDF)