MOST FREQUENTLY ASKED QUESTIONS ON IVDR -- MEDICA - World Forum for Medicine

11/08/2022

Obelis SA OBELIS GROUP

MOST FREQUENTLY ASKED QUESTIONS ON IVDR

This document has been conceived for in-vitro diagnostic manufacturers to provide information on the impact of the new IVDR.

  • Which devices can be sold as legacy devices under IVDR after May 26, 2022?
  • Can I sell IVDR-compliant devices before the date of application (DoA) of IVDR?
  • Can I sell devices after the IVDR DoA?
  • How is covid testing regulated under IVDR – Regulation (EU) 2017/746?
  • What is the “sell-off” provision about?
  • What are the obligations of the manufacturer under IVDR?


Exhibitor Data Sheet