IVDR: Understanding the transitional provision

Abstract

The new EU IVDR was enacted in May 2022. Are you up-to-date on which requirements now apply to all devices starting May 2022, and what products are impacted by the updated transitional arrangements?

There have been several factors that have contributed to health institutions and companies being unable to comply with the new requirements coming into effect on the 26 May 2022; however, the extension of the transitional arrangements does not apply uniformly across all in vitro diagnostics (IVDs) and is not a delay to the date of application.

Join Sue Spencer, Principal Consultant at Qserve Group, Erik Vollebregt, Partner at Axon Lawyers, and Dr. Julien Senac, Global Director of the IVD Focus Team at TÜV SÜD, for more details on the transitional arrangements, whether and how your IVD might be impacted, and how to comply with these additional provisions.