Forms in the field of medical devices

Registration of legal entities in the register of activities

• FORM A - Entry into the register of manufacturers of medical devices

• FORM B - Entry into the register of legal entities wholesaling medical devices

• FORM C - Entry into the Register of legal entities who perform retail of medical devices

• ANNEX 1 - List of locations/manufacturers/specialised stores

• ANNEX 2 - Classification of medical devices
  

• ANNEX 3 - List of manufacturers

• Application for a certificate of registration in the register of activities of medical devices

Registration of medical devices

• Form MedPri-MP-obr07 Application for notification of entry a medical device in the register of medical devices (mandatory)
• Annex A MedPri-MP-obr07 First entry in the register  (mandatory)
• Annex B MedPri-MP-obr07 Entry without a change in the register (mandatory)
• Annex C MedPri-MP-obr07 Entry with a change in the register (mandatory)
• Annex 2 MedPri-MP-obr07 Information on medical device which are combined in a system or procedure pack (complete only if necessary)
• Annex 3 MedPri-MP-obr07 Information on accessories to the medical device (complete only if necessary)
• Annex 4 MedPri-MP-obr07 Information on packaging (complete only if necessary)
• Form MedPri-MP-obr08 Application for notification of entering an in vitro diagnostic (IVD) medical device in the register of medical devices (mandatory)
• Annex A MedPri-MP-obr08 First entry in the register (mandatory)
• Annex B MedPri-MP-obr08 Entry without a change in the register (mandatory)
• Annex C MedPri-MP-obr08 Entry with a change in the register (mandatory)

Declaration of free sale

• MedPri-MP-obr09 Application for obtaining a Certificate of free sale for medical devices

Vigilance of medical devices

• MedPri-VIG-obr01 Notification on incident involving a medical device

• MedPri-VIG-obr02  Manufacturer’s Incident Report Form

• MedPri-VIG-obr03 Field Safety Corrective Action Report Form

• MedPri-VIG-obr04 Field Safety Notice template

Clinical investigations and performance evaluation studies of medical devices

• MedPri-MP-obr03 Application form notification of a clinical investigation
• Annex A MedPri-MP-obr03 Information on locations of clinical study sites
• MedPri-MP-obr04 Application for notification of a change of clinical investigation of a medical device
• MedPri-MP-obr05 Application for notification of a performance evaluation study of an in vitro diagnostic medical device
• MedPri-MP-obr06 Application for notification of a change of performance study of an in vitro diagnostic medical device

Notified body

• MedPri-MP-obr02 Designation of a notified body

Classification of a product as a medical device

• MedPri-MP-obr01: Application for classification of a product as a medical device