Medtech

EUDAMED (European Database on Medical Devices) is the information system developed by the European Commission. This database will be multi-purpose and interoperable and will function as a collaborative, record-keeping, reporting and dissemination system of information also available to the public.

The final planned configuration will consist of a public website and six different interconnected electronic systems (“modules“):

• Actor Registration
• UDI and Device Registration
• Notified Bodies and Certificates
• Clinical investigations and performance studies
• Post-market Surveillance and Surveillance
• Market Surveillance

RPN supports performance of the Economic Operator Registration procedure within the EUDAMED database for EU and non-EU Manufacturers, Authorized Representatives, System Manufacturers and for the Importers of Medical Devices and In-Vitro Diagnostic Devices.

RPN constantly follows updates on the development status of EUDAMED and provides registration support for the active modules of EUDAMED, up to notification to the Ministry of Health of the referring Member State, which will issue the SRN code (Single Registration Number) upon activation from authorization.

RPN also supports in those cases where registrations are needed at the local level – depending on the classification of the devices – in the single European countries.