Clinical Investigations: Biological Safety Assessments
Summary
MHRA has published guidance on biological safety assessments for clinical investigations of medical devices, outlining the information required in submissions to verify compliance with applicable regulations. The guidance applies to all sponsors and clinical investigators planning clinical investigations of medical devices in the UK and specifies MHRA's expectations for biological safety evaluation documentation. Organisations conducting or planning clinical investigations involving medical devices should review these requirements as part of their regulatory submission preparation.
“This guidance sets out the information that the MHRA expects to be included in a clinical investigation submission, so that we can verify that the requirements of the relevant regulations have been met.”
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
This guidance from MHRA sets out the information required in a clinical investigation submission for a medical device, specifically focusing on biological safety evaluation requirements. The document is intended to help sponsors and clinical investigators understand what MHRA expects to verify regulatory compliance before a clinical investigation can proceed.
Affected parties—sponsors, clinical investigators, and manufacturers of medical devices—should review this guidance when preparing clinical investigation applications for submission to MHRA. The biological safety assessment must be completed before undertaking any clinical investigation of a medical device in the UK.
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: biological safety assessments
How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.
From: Medicines and Healthcare products Regulatory Agency Published 30 March 2026 Get emails about this page
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This guidance sets out the information that the MHRA expects to be included in a clinical investigation submission, so that we can verify that the requirements of the relevant regulations have been met.
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Published 30 March 2026
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