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
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
Classification of a product as a medical device