IVD Monthly Newsletter
Dear reader,
The EU has decided to grant additional time, a significant chunk of it, to those IVD manufacturers who are committed to transitioning their devices, or similar ones, to the IVD-Regulation. At the same time, it also granted the same extension to the Notified Bodies which will be involved in reviewing such devices together with the quality management systems of their manufacturers. This is the second significant postponement, following the initial one in January 2022 due to COVID-19 disruptions.
This latest move, though presented as a "technical adjustment", is likely a response to the industry's slow adoption of the IVDR. Surveys show a concerning lack of submissions and approvals. While some big players are ready or nearly there, many manufacturers are lagging.
For the sake of the IVD industry and the overall benefit of the EU, we all must strive to make the new EU regulatory framework for IVDs a success and not a failure. Politically and technically, we won’t be able to afford a 3rd postponement. Industry must understand that they must act now and avoid falling into the trap of postponing – again – their IVDR compliance projects because: “there is still time”. Time is now and acting now is the only road to IVD-R compliance. The good news is: we are here to help you along the way.
Happy reading!
CATCH UP ON THE IVDR EXTENSION?
Missed our webinar on "IVDR Extension Explained: Tips & Strategies?
No worries, we didn't want you to miss out on these valuable insights, that's why you can now rewatch the recording and learn about the proposed transitional IVDR extension and its impact on your daily operations and long-term strategies. ???
The perk of attending a webinar live is that you can ask your personal questions. But we know schedules can get too busy to follow a full webinar, so if you have any questions regarding the IVDR, the proposed transitional extension, or its implications for your specific situation, don't hesitate to reach out to Jens Vandormael . He is more than happy to help.
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IVDR Extension What does this mean for you?
In this whitepaper, we delve into the implications of the IVDR transition extension under proposal 2024/0021 (COD) and offer tips and strategies on how to best navigate the evolving regulatory landscape to ensure continued compliance and innovation in the IVD industry.?
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