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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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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.
No one should underestimate the scale of the obstacles companies face trying to comply in time with the IVD Regulation by its 26 May 2022 deadline, especially now data is starting to emerge to highlight the size of the problem.