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 clinical investigations and the market surveillance modules of the new version of the EU medical device database, Eudamed, are reported to be causing the biggest challenges when it comes to setting up all six modules so that the entire database can be launched in 2022.
“We may even see Eudamed being launched officially with one or both missing, Ronald Boumans, senior consultant, regulatory affairs Emergo by UL, speculated.
