IVDR April 2025
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'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.'
As we move into 2025, the regulatory landscape for IVDR continues to evolve. In 2024, we shared the updates on the upcoming changes and now we’re providing the latest insights in 2025 to ensure you stay informed and prepared.
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Ratatouille réglementaire au labo : IVDR, ISO 15189 et cie
La norme ISO 15189 n’est qu’un ingrédient dans la recette complexe de la conformité IVDR. Les laboratoires possédant des dispositifs internes (In House-IVD/LDT) ont besoin d’un mélange savoureux d’ingrédients réglementaires qui se chevauchent et s’assemblent au sein d’une même marmite. Le résultat peut paraître désordonné, mais une méthode pratique se cache derrière.
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.
