No Eudamed, No Problem! Latest Guidance Explains Alternatives While Database Is Built
Lack of an official explanation about how the exchange of critical information will progress pending the launch of the EU’s medical device database, Eudamed3, has left many confused. New guidance lights the way forward.
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Not enough resources and the lack of readiness of the clinical investigations module are being blamed for a possible further two-year delay in the launch of the EU’s critical medtech database.
Information exchange and transparency are at the heart of the EU’s new medtech regulatory system. Despite delays in building the new version of the Eudamed medical database, the commission is encouraging its use as each building block becomes available.
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