Application/Notification for grant of operation notice on medical device-related activities download document … download document …

Application for change of operation notice on medical device-related activities download document … download document …

Application/Notification for record into the national database of EU/EEA resident medical device service providers download document … download document …

Application for grant of notice for use of medical devices descarca documentul … descarca documentul …

Application for grant of periodic check bulletin for medical devices download document … download document …

Application for grant of periodic check bulletin for medical devices in use by mobile intervention units download document … download document …

Application for grant of notice for use of medical devices in use by mobile intervention units download document … download document …

Application for grant of notice for use of diagnostic and therapeutic medical devices by ionising radiation, nuclear medicine and MRI download document … download document …

Application for grant of periodic check bulletin for diagnostic and therapeutic medical devices by ionising radiation, nuclear medicine and MRI download document … download document …

Application for grant of periodic check bulletin for medical devices radioprotection equipment download document … download document …

Application for grant of customs notice download document … download document …

Application for grant of out-of-scope notice download document … download document …

Payment form grant of out-of-scope notice – customs notice descarca documentul … descarca documentul …

Form – Report on medical device related incidents – for users download document … download document …

Form – Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) Reporting Template Version 7.2.1 download document …

Application for clinical investigation download document … download document …

Contents of the clinical investigation dossier download document … download document …

F1 Form download document … download document …

F2 Form download document … download document …