EU 2015: Tough Year For Notified Bodies and For Negotiations On New Regulations
This article was originally published in Clinica
As 2015 draws to a close, Clinica looks back on the articles that have been most popular with our subscribers.
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Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.
The European Commission’s announcement of a lengthy delay to the Eudamed database launch date has generally been met with dismay, with member states challenging the decision. Now there is news of a concession.
Not only is the EU due to be endorsing key guidance documents this week, but recent headline topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.