While we are happy and relieved for the IVD industry to have an extension to the IVDR transition period, we’re concerned that the announcement may result in a misperception that there is plenty of time to get the work done.
In this technical video, we dissect the regulation and show visually what a manufacturer needs to accomplish on the revised timeline, including:
➕ Description of the extension to the IVDR transition period,
➕ Detailed description of the impact to each device classification as well as in-house devices,
➕ Proposed step-by-step product journey on the revised timeline including expected challenges,
➕ Predicted notified body product review timelines and concerns, and
➕ Post CE certification work to plan for.
Watch the video below for everything you need to know in less than 30 minutes.
![](https://play.vidyard.com/Tj2z99V5pWgWpBCrTUgnwU.jpg)
Looking for related content? Download our white paper, “Performance Data and EU IVDR”.