New EU Regs Will Offer No Reprieve From Borderline Classification Chaos
Challenges will persist for borderline and combination products under the new EU regulatory structure so manufacturers need to continue to pay close attention when determining the classification of these products.
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The borders between medical devices, pharmaceuticals and even nutraceuticals are so fine that many companies seek to cross these subtle lines in order to gain regulatory or marketing advantage over their competitors. Often, this is achieved with success – although sometimes on shaky ground.
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.
2020 is not getting off to a good start for manufacturers needing to comply with the EU’s new Medical Device Regulation on 26 May 2020. The European Commission’s latest document seems to confirm industry’s fears about the ability of the EU’s medtech system to be ready in time.