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