Commission's Go-Live Date For New Eudamed Medical Device Database: Will It Actually Be Met?
Many questions surrounding compliance with the data submission requirements under the new Eudamed database remain outstanding. How should companies plan their submissions in the face of these uncertainties? And will the database even be ready on time, or will it be subject to a delay of up to six months?
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While Eudamed is largely on track, there could be a few months of delay in the availability of certain critical parts of the EU's updated medical device database. Stakeholders are working toward a May 26, 2020, deadline for the full application of the EU Medical Devices Regulation, including Eudamed.
Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?
The European Commission is optimistic that work on standards for the new EU medtech regulations will begin as soon as May. After previous setbacks, the medtech sector is pinning it hopes on the EU standards bodies, CEN and Cenelec, accepting the Commission’s latest proposal