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Commission Publishes Implementing Regulation That Acts As Basic Starter Manual For Eudamed

 
• By Amanda Maxwell

The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.

Regulation cogs (EtiAmmos/Shutterstock.com)

The Implementing Regulation laying down rules for the application of the MDR as regards Eudamed details the processes that actors must go through to obtain access to the European medical device database, explains that authorized users should use the free-of-charge European Medical Device Nomenclature codes when accessing the database, and details what help and training will be available.

In addition, it covers what happens if fraudulent activity, malfunctions, or if

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