Overview

The IVDR has applied since 26 May 2022. On 23 January 2024, the EU Commission released a proposal to further extend the transitional period for IVDs. This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements.

This webinar provides an overview on the new IVDR transitional timelines and key changes impacting IVDs. We will highlight the actions that manufacturers will need to take to ensure timely compliance with the IVDR, especially with regards to legacy IVD devices and the steps that BSI is taking to support IVD manufacturers through applications and review processes to foster IVDR transition.

Key takeaways and learning objectives

What will participants gain?

• A better understanding of the new IVDR transitional timelines and key changes impacting IVD manufacturers pursuing CE marking under the IVDR
• An understanding of the steps BSI is taking to support them during the application and review processes, to foster timely compliance with the IVDR

Presenter information

Speaker - Alex Laan, Head of Notified Body, IVD

Speaker - Sara Fabi, Regulatory Lead - Notified Body, IVDR