As the countdown begins to the EU IVDR date of application, are you aware of which requirements will 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.
Learning objectives:
- What is the change to the transitional arrangements for IVDR?
- What is the status of notified bodies and application for approval of new devices?
- What are the economic operator obligations for legacy devices?
- Does the Clinical Trial Regulation apply to IVDs or IVDs used in clinical trials?
