Clinical Investigations: Investigators' Responsibilities for Medical Devices
Summary
MHRA has published guidance on investigators' responsibilities for medical device clinical investigations. The guidance explains what must be included in submissions notifying MHRA of a manufacturer's plans to undertake a clinical investigation, covering the approval process, conduct requirements, device labelling, and required documentation. Clinical investigators planning medical device studies in Great Britain should review this guidance to ensure their submissions meet current MHRA requirements.
“This guidance helps clinical investigators understand what needs to be included in a submission notifying the MHRA of a manufacturer's plans to undertake a clinical investigation, including our approval process, conduct, labelling of devices and what documentation you need to provide.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
MHRA has issued new guidance detailing the responsibilities of clinical investigators conducting medical device investigations. The guidance covers the submission requirements for notifying MHRA of planned clinical investigations, including the approval process, conduct standards, device labelling requirements, and documentation that must be provided.
Clinical investigators and manufacturers planning medical device clinical investigations in Great Britain must ensure their submissions align with this guidance. Investigators should familiarise themselves with the specific documentation and labelling requirements outlined to avoid delays in the MHRA approval process. Healthcare institutions and sponsors working with medical devices should review their clinical investigation procedures against these published standards.
Archived snapshot
Mar 30, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Guidance
Clinical investigations: investigators' responsibilities
How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.
From: Medicines and Healthcare products Regulatory Agency Published 30 March 2026 Get emails about this page
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This guidance helps clinical investigators understand what needs to be included in a submission notifying the MHRA of a manufacturer’s plans to undertake a clinical investigation, including our approval process, conduct, labelling of devices and what documentation you need to provide.
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Published 30 March 2026
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