Application for clinical investigations of medical devices

Guidance

Guidance on how to apply for the authorisation for clinical investigation of medical devices on human subjects 

Regulatory requirements for clinical investigations of medical devices 

Forms

Application form for the authorisation of clinical investigations of medical devices

Application form for the authorisation to make changes and amendments to the clinical investigation

Notification of the completion of clinical investigations of medical devices

Notification of serious adverse events and near-incidents during the clinical investigation

EU Commission's SAE Reporting form