Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database
IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical device database will be postponed again, what will this mean for stakeholders?
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While nothing is official yet, it seems that the EU is likely to struggle to have two of the six Eudamed modules ready on time. Might this mean a further delay, or will the system be officially launched without them?
This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry of new IVD guidance documents and some serious debates over hitches encountered in the implementation of the MDR and IVDR.
In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.