MHRA has issued new guidance establishing the information requirements for biological safety assessments in medical device clinical investigation submissions. The guidance clarifies what data and documentation sponsors must include to demonstrate compliance with UK regulations before receiving approval to proceed with clinical investigations involving medical devices.

Sponsors and manufacturers preparing clinical investigation applications for medical devices should review this guidance and ensure their submission packages include all required biological safety evaluation information as specified by MHRA. Compliance with these requirements is necessary for regulatory approval of clinical investigations in the UK.