We strongly welcome the proposed amendment of Article 5(5) of the IVDR. The revision represents a pragmatic and balanced approach that strengthens patient access to high-quality diagnostic services while maintaining appropriate safeguards for safety, quality, and performance.
VKGL, Dutch Society for Laboratory specialists clinical genetics
NGO · Netherlands
Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
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Their record over time
VKGL, Dutch Society for Laboratory specialists clinical genetics filed 2 positions between 3 Oct 2025 and 27 Jul 2026, across 1 of the 326 legislative files tracked here.
What they argued
We welcome the Commissions initiative to simplify EU regulations for in vitro diagnostics, while safeguarding both patient safety and fostering innovation. First of all, we fully support the urgent call opinion paper by Cobbaert et. al (https://doi.org/10.1515/cclm-2025-1033).
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