European Commission to launch first EUDAMED module

The European Commission (EC) has announced the launch of the first module of EUDAMED, the database for medical devices, on 1 December.

The Actor registration module will allow economic operators and European health authorities to prepare for the new European regulations for medical devices that come into force in May 2021, having been postponed due to COVID-19. It is the first of six EUDAMED modules.

The Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) encourages all operators based in France to register on EUDAMED from 1 December in order to familiarise themselves with the database, use of which will become mandatory from May 2022.

Economic operators will be able to register on the Actor module on a voluntary basis from the beginning of December. This includes all manufacturers and importers of medical devices.

For further information and guidance on registration, see the ANSM article and European Commission page in the related links.

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Published on 27. November 2020 in News, News EU, Press Release