Europe – Eudamed actor module FAQ now live

The European Commission has published an FAQ document covering the Eudamed Actor Registration Module on the Eudamed Actors page.

The new FAQ document mainly provides background information needed to understand the context of the Eudamed medical device and IVD database, who should be using it and what they need to prepare. The Actor Registration Module enables the so-called “economic operators” (Manufacturers, Authorized Representatives, Systems and Procedure Pack Producers, but not distributors; see this infographic) to register themselves in the database. This module can be used from December 1st, 2020. For now, the use of this module is on a voluntary basis because Eudamed only becomes applicable after all component modules are ready and the database’s launch has been formally announced in the Official Journal of the European Union…