Critical EU Authorities Meeting Next Week Could Be Make-Or-Break For Many Medtech Companies
The EU medtech industry is trying to put the brakes on the full application of the new Medical Devices and IVD Regulation as a logjam looms. What is it doing to succeed? And why is time running out?
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The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for the Medical Device and IVD Regulations. What more do we know after last week's crucial Medical Device Coordination Group meeting?
Huge numbers of products risk failing to comply the new EU regulations in time. Are efforts to extend deadlines legally and practically possible and will they be supported? MedTech Europe's Oliver Bisazza talks with Medtech Insight.
It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.