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?
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?