A targeted revision of MDR and IVDR is necessary to restore predictability, protect patient safety, and safeguard access to the health technologies that citizens rely on. Without improvements to how the framework operates in practice, delays, uncertainty and disproportionate requirements risk limiting availability of existing technologies and slowing access to new innovation.
ABHI
Industry association · United Kingdom
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
ABHI filed 2 positions between 6 Oct 2025 and 9 Jun 2026, across 1 of the 326 legislative files tracked here, attaching a full position paper 2 times.
What they argued
ABHI welcomes the European Commissions targeted evaluation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Representing UK HealthTech manufacturers, developers and service providers across the UK, EU and global markets, ABHIs submission reflects collective member experience and highlights areas for targeted revision to support patient access, innovation and regulatory…
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