All economic operators in the European territory and non-EU manufacturers, authorized representatives, system/procedure pack producers, and importers must register as an actor in EUDAMED and provide the required data. The actor registration module of the European Commission’s Eudamed database, which is a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR),

Economic operators established in the EU or with authorized representation in the EU can now register. Economic operators headquartered in the United Kingdom, Switzerland, and Turkey will be unable to register unless agreements are negotiated between those countries and the EU.

The actor module, which is required to access and use EUDAMED, enables economic operators to receive a single registration number (SRN), which serves as an EU-wide unique identity. The EUDAMED actor module also includes a searchable database of registered economic operators and competent authorities, allowing users to get information about the actors, such as contact information and identity, as well as information on the firms’ accountable individuals for regulatory compliance.

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