How to Obtain Regulatory Advice from the MHRA for Medical Devices

1. Purpose of regulatory advice meetings

The regulatory advice service offered by the Medicines and Healthcare products Regulatory Agency (MHRA) is designed to provide guidance on the interpretation and application of medical device and in vitro diagnostic (IVD) device regulatory requirements where existing published guidance may not be straightforward. It is intended to clarify regulatory expectations and support compliance planning. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])

2. When to request advice

Manufacturers, sponsors, or other stakeholders may request regulatory advice when:

• The application of regulatory guidance is unclear
• Novel technology or borderline classification questions exist
• There are complex compliance or procedural issues not fully addressed in existing guidance

The MHRA encourages reviewing all relevant published guidance before requesting a meeting to ensure questions are not already answered in guidance documents. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])

3. How to request a meeting

To request a regulatory advice meeting, interested parties must complete a meeting request form provided by MHRA. Meetings typically involve preparation of questions and relevant background information to enable productive discussion during the session. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])

4. Fees and process

The MHRA charges fees for regulatory advice meetings, which may vary depending on the duration and scope of the meeting. Participants are usually required to pay in advance and provide details of their regulatory questions and device context ahead of the scheduled session. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])

5. What happens during and after the meeting

During the meeting, MHRA regulators discuss specific regulatory challenges and provide advice on applicable UK requirements. After the meeting, participants may receive summaries or follow-up guidance based on the discussions, aiding their regulatory planning and compliance activities. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])

6. Limitations of MHRA advice

MHRA’s regulatory advice service does not:

• Provide consultancy on specific product design, development, verification, validation, or manufacturing aspects
• Offer insights into future regulation development
• Replace formal structured dialogue with an approved body
• Issue endorsements or long-term collaborative support

The service focuses on clarifying current regulatory requirements, not guaranteeing approval outcomes. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])

7. Complaints and feedback

Users of the regulatory advice service who are dissatisfied may raise complaints with the MHRA following the agency’s established complaints procedures. Feedback on the service assists ongoing improvement of MHRA’s engagement with stakeholders. Source: Medical devices: get regulatory advice from the MHRA ([GOV.UK][1])