Rolling On: EU Makes Good Progress On Structures For New Regs Implementation
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.
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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.
A new "rolling plan" provides deadlines for implementing actions, and other efforts, that are necessary to get the new EU Medical Device and IVD Regulations off the ground.
Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.