FORMS IN THE FIELD OF MEDICAL DEVICES

REGISTRATION OF LEGAL ENTITIES IN THE REGISTER OF ACTIVITIES

Register of manufacturers of medical devices

• FORM A – Entry into the register of manufacturers of medical devices
• ANNEX 1 – List of manufacturing sites
• ANNEX 2 – Classification of medical devices

Register of legal entities wholesaling medical devices

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

Register of legal entities retailing medical devices in specialised stores

• FORM C – Register of legal entities retailing medical devices in specialised stores

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

• 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 – NEW – Manufacturer Incident Report (MIR v.7.2) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) (Helptext_MIR_v.7.2)
• 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