The latest IVDR Report from Diaceutics
Where are we now in molecular testing?
'After different delays and not without concerns, the implementation of IVDR, the new regulatory framework for in-vitro diagnostic in the EU, has now started. Molecular testing in oncology is likely to be one of the areas in which this legislation will have a bigger impact, with questions and concerns having been raised by all the stakeholders involved in biomarker testing. However, IVDR is here to stay, and laboratories are facing a transition period in which they will need to adapt to this new reality.'
IVDReady To Go
The IVDReady Webinar Series offers labs the know-how and insights needed to tackle IVDR fulfillment, while also demonstrating our regulatory platform for getting the job done faster.
Platomics’ next webinar with Prof. Dr. Folker Spitzenberger brings us up-to-date on changes to IVDR requirements and the implementation timeline. He also offers a glimpse of up-and-coming ISO 5649 for Lab-Developed Tests.
Special guest, Prof. Dr. Ronald Simon from molecular pathology at the University Medical Center Hamburg-Eppendorf will give insights on how his lab is tackling IVDR compliance.
July 9th, 2024
2pm-3pm CEST
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Watch the session!
The implementation of the new CE-In Vitro Diagnostics Regulation (IVDR) involves challenges faced by labs that are working within the diagnostic environment. This event provided an overview of how IVDR implementation is progressing in different countries, and which are the most relevant challenges from a molecular pathology point of view. Five guest speakers from France, Spain, Italy, and the UK with experience in the field will share their point of view and discuss the current situation and future perspectives.
