UK MHRA Med. Dev Guidance: Clinical Investigations in the UK: When & How to Notify MHRA

Conducting clinical investigations for medical devices in the UK requires strict adherence to MHRA’s updated regulatory framework, designed to support patient safety, device innovation, and compliance with evolving UK (and EU for Northern Ireland) requirements.

The guidance  “Notify MHRA about a clinical investigation for a medical device” provides a clear roadmap for manufacturers, sponsors, and investigators who plan to conduct clinical investigations of medical devices in Great Britain.

• Clinical investigation (medical device): Research involving human subjects to assess the safety or performance of a medical device.

• UKCA/CE/CE-UKNI marking: Conformity marks that indicate a device meets regulatory requirements for Great Britain (UKCA) or European markets (CE).

  
  

When is notification required?

You must notify MHRA before starting a clinical investigation if the device under study is either:

• Not currently UKCA/CE/CE UKNI-marked for the intended purpose under investigation, or

• A UKCA/CE/CE-UKNI marked device being used for a new purpose or modified use.

If the device is already UKCA/CE/CE-UKNI marked and the investigation uses it for the same intended purpose, you may not need MHRA notification.

What does the process look like?

• Submit your intention to MHRA via the appropriate route (often through the Integrated Research Application System (IRAS) or as advised).

• MHRA will validate your submission — once validated, they will confirm the start of the statutory assessment period (typically up to 60 calendar days).

• During the assessment, MHRA evaluates the device, the proposed investigation plan, patient safety, risk/benefit, investigator competence and ethical approval.

• You must not start the investigation until MHRA gives a “no objection” or the statutory timeframe has passed, unless otherwise specified.

What information should you include?

Your notification/application should include details such as:

• Device description (including classification, UKCA/CE status, manufacturer, UK responsible person if non-UK).

• Intended purpose of the investigation, design of study, target population.

• Investigator brochure or equivalent device information.

• Clinical investigation plan (CIP) covering endpoints, methodology, risk-management, monitoring.

• Ethical approval or planned ethics review process.

• Labelling, instructions for use, any modifications being tested.Detailed checklists and templates accompany the guidance.

Special considerations

• Studies involving sites in Northern Ireland may need to follow EU MDR-aligned requirements.

• If you plan significant modifications to the device, or intend to use it outside the authorised purpose, you should treat this as a full clinical investigation and notify MHRA accordingly.

• Amendments to the investigation (e.g., site change, device change, protocol modification) may also need notification and approval.

Actions for sponsors & manufacturers

• Review whether your device and investigation scenario require notification under the guidance.

• Prepare your internal timeline with key milestones: device classification, ethics application, MHRA submission, 60-day assessment, start of investigation.

• Use the MHRA checklists to prepare a complete application package. Clinical investigation application checklist.

• Ensure roles and responsibilities are clear (manufacturer, UK responsible person, sponsor, investigator).

• Monitor any changes during the investigation and have an amendment-management plan ready.

By following this guidance, you reduce regulatory risk, support data integrity and align with MHRA expectations for device evidence generation.

For more details, please refer to the MHRA guidance: Notify MHRA about a clinical investigation for a medical device.