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...
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?
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.
The European Council has paved the way for swift adoption of the proposal to amend the IVD Regulation, given the pressures the IVD sector is under. All eyes are now on the European Parliament.