Aside the technical requirements of the new Regulation, there are a number of uncertainties which may act as showstoppers if are not resolved in due time.
The main uncertainties are related to
- the timely availability of a sufficient number of appropriate Notified Bodies,
- the timely availability of the central database Eudamed,
- the fate of legacy products, particularly taking into account the different interpretations that we start hearing on the transitional measures including the so-called “grace period”
- the clinical requirements for the same legacy products and, in general, on all class III and implants
- the still undefined shape of the UDI
- and, over all, the availability of resources at Member States and Commission level
Overall clarity on the governance of the new system is needed.
Presented by Dario Pirovano | Senior Regulatory Adviser, MedTech, Europe