FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

European Commission Clarifies What UDI Info Is Needed for Eudamed

May 15, 2019
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The European Commission released new details on the datasets devicemakers should include in the Eudamed database that will be used to monitor the safety and performance of devices under the EU’s Medical Device Regulation and In Vitro Diagnostic Regulation.

The overriding principle for the database is that each unique device identifier (UDI-DI) inherits the attributes of its linked Basic UDI-DI—the primary identifier of a device model and the main key for records in the UDI database that’s referenced in certificates and EU declarations of conformity.

The device data requirements are broken down by mandatory requirements, mandatory requirements if applicable and optional requirements.

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