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 in the register of specialised stores involved in 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 involving medical devices

Registration of medical devices

• Form MedPri-MP-obr07 Notification of entry of a medical device to the medical device register

• Annex MedPri-MP-obr07 Information on individual medical device

• Annex 2 MedPri-MP-obr07 Information on medical devices which are combined in a system or procedure pack

• Annex 3 MedPri-MP-obr07 Information on accessories to a medical device

• Annex MedPri-MP-obr07 Information on packaging of a medical device

• Form MedPri-MP-obr08 Notification of entry of an in vitro diagnostic medical device into the medical device register

• Annex MedPri-MP-obr08 Information on individual IVD medical device

Declaration of free sale

• MedPri-MP-obr09 Obtaining a declaration 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 Notification of a clinical investigation

• Annex MedPri-MP-obr03 Information on clinical study sites

• MedPri-MP-obr04 Notification of an amendment to the clinical investigation of a medical device

• MedPri-MP-obr05 Notification of a performance evaluation study of an in vitro diagnostic medical device

• MedPri-MP-obr06 Notification of an amendment to performance evaluation 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 Classification of a product as a medical device