What is the webinar about?
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.
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
Who should attend?
Manufacturers of In Vitro Diagnostic devices, in particular those transitioning IVDD-certified devices to the IVDR, manufacturers who have not yet placed an IVD on the market in the EU, and other Economic Operators including importers, distributors, authorized representatives, and consultants who are working towards or supporting CE marking under the IVDR.
Choose from one of two sessions on Tuesday 23 April 2024
09:00 - 10:00 BST - Register here
16:00 - 17:00 BST - Register here
Speakers
To find out more about IVDR and the extension to the IVDR transition timeline, visit our dedicated IVD webpage.
Email: medicaldevices@bsigroup.com
Phone: +44 3450809000
