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

Documents

Biological safety assessment

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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.

Published 30 March 2026