FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

European Commission Releases Details on Eudamed, Nomenclature System

April 3, 2019
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The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations.

The document is the first draft guidance the commission has released that provides details of functional specifications of the Eudamed database for devices and IVDs. The new regulations go into effect on May 26, 2020 for devices and on May 26, 2022 for IVDs.

Eudamed is “a keystone for the implementation of the new regulations,” enabling device traceability and better market surveillance, the commission said.

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