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?
You may also be interested in...
Not enough resources and the lack of readiness of the clinical investigations module are being blamed for a possible further two-year delay in the launch of the EU’s critical medtech database.
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?
The EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.