IVDR: where are we now in molecular testing? How IVDR implementation is progressing in molecular biology laboratories in different European countries
IVDR, the new EU legislation for in-vitro diagnostic, came into effect in May 2022. However, it´s implementation is significantly delayed (with the EU just having agreed on a further 2-year extension of the deadlines for all types of products), and there are still many concerns and questions to be answered. Molecular testing in oncology is likely to be one of the areas in which this legislation will have a bigger impact, and laboratories are facing a transition period in which they will need to adapt to this new reality. It´s important to understand which steps have the different European countries taken in this process, and how the labs consider that IVDR implementation is progressing in each one of them and what are the biggest challenges that need to be addressed. The diagnostic test manufacturing industry will also need to adjust to the new situation.
This report discusses the insights and opinions shared by molecular pathology lab and industry experts in the “CE-IVDR: where are we now in molecular testing?” round table organized by Diaceutics, moderated by Dr. Dave Smart (Diaceutics) and with the participation of Dr. Etienne Rouleau (Chief of Tumor Genetic Laboratory at Gustave Roussy, France), Dr. Maria Scatolini (Head of Molecular Oncology Laboratory at “Edo ed Elvo Tempia Foundation” in Biella Hospital, Italy), Dr. Javier Hernández Losa (Head of the Molecular Biology Laboratory in the Pathology Department at Vall d´Hebrón University Hospital, Spain), and Dr. Bastiaan Tops (Head of Laboratory for Childhood Cancer Pathology at Prinses Máxima Centrum, The Netherlands), together with Jennifer Stobbs (Senior Product Marketing Manager IVDR Europe at Illumina).
Key Takeaways
- How IVDR implementation is moving forward in the context of molecular biology in oncology in The Netherlands, France, Italy and Spain
- What steps have been taken in each country and what are the remaining challenges and concerns that need to be addressed
- How a lack of information and awareness can impact the implementation of the new legislation
- How the diagnostic test manufacturing industry is adapting to the new legislation and how can it contribute to make the transition easier for the labs
- How the new legislation can impact the use of laboratory developed tests (LDTs), commercially available tests and biomarker testing in clinical trials
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