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Information for citizens
Information for medical specialists
Information for companies
Home Medical devices
Medical devices

Guidelines on Medical Devices Vigilance System (There are no translations available)

Template for a Field Safety Notice

Template for National Competent Authority Report (There are no translations available)

Report Form Manufacturer's Incident Report (initial/final incident report)

Report Form Field Safety Corrective Action

Incidents/ potential incidents Report Form for medical devices, in accordance with art.104 of MDL