Eudamed - A Moving Target But On Track For March 2020 Partial Go-Live
While Eudamed is largely on track, there could be a few months of delay in the availability of certain critical parts of the EU's updated medical device database. Stakeholders are working toward a May 26, 2020, deadline for the full application of the EU Medical Devices Regulation, including Eudamed.
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The European Commission has updated its EU MDR and IVDR implementation Rolling Plan to reflect the latest developments on the much-needed structures for implementing the new Regulations. The most recent update addresses UDI, Eudamed and Common Specifications for high-risk class IVDs.
Many questions surrounding compliance with the data submission requirements under the new Eudamed database remain outstanding. How should companies plan their submissions in the face of these uncertainties? And will the database even be ready on time, or will it be subject to a delay of up to six months?
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.