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About medical devices
Medicinskudstyr
Clinical investigations
Application for clinical investigations
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Clinical investigations
Regulatory requirements for clinical investigations
Application for clinical investigations
Amendments to a Clinical Investigation
Fees for clinical investigations
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
Created 29 December 2005, Updated 16 December 2011