Major Regulatory Compliance Challenges

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