EU’s Eudamed Database: Crucial To New Regs, But Will It Be Ready in Time?
The EU must have its new Eudamed database operating smoothly to support the implementation of the new IVD and Medical Device Regulations. But experience with its predecessor suggests progress may not always be straightforward.
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How much faith do medtech regulatory experts have in the forthcoming medical device and IVD regulations and will they be ready on time? While the EU is making significant progress, experts continue to have serious concerns about implementation of the new regulations and the impact on industry.
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.