Two New Modules Added To Eudamed For Use On Voluntary Basis
The latest version of the Eudamed medical device database has been upgraded and kickstarts the sharing around the EU of more key regulatory information.
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Despite IT system enhancements tending to take longer than expected, the European Commission’s expansion of the Eudamed medical device database looks imminent and to arrive just about on time.
While it was obvious to those in the sector that the implementation of the EU IVD Regulation was heading for a disaster, this article looks at the facts and figures that helped sway the European Commission to propose new transition periods to better manage its implementation.
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.