EU Regulatory Roundup, December 2019: A Veritable Avalanche Of Key Decisions And Documents
December 2019 was a big month for far-reaching EU medtech regulatory developments that will have a significant impact on the way and speed of implementation of the Medical Device Regulation.
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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.
The European Commission promised 20 medtech notified body designations by the end of 2019 but has fallen far short of its target. The medtech sector only has 12 notified bodies and could be about to lose two designations.