# Clinical investigations: biological safety assessments

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/cc55edcf-60c9-4da2-837e-92ad5a6bc664
Type: Guidance
Published: March 30, 2026

> How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.

---

## Content

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.

## Attachments

- [Biological safety assessment](/government/publications/clinical-investigations-biological-safety-assessments/biological-safety-assessment)