The eagerly anticipated European Commission’s proposal to simplify rules on medical and in vitro diagnostic devices was released in late December 2025.
What does this mean for sponsors?
There are several welcome amendments listed, including the addition of Breakthrough/Orphan Device pathways, combined, coordinated submissions and assessments of Companion Diagnostics, and the expansion of the Health Institution Exemption to include Central Laboratories that support Clinical Research.
LabConnect expert Jennifer Russell has curated a summary outlining impact on the Clinical Research Industry, including key proposals and potential IVDR scope creep, with a request for minor modifications.
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