21/03/2025

iCARE4CVD contribution to EU review of rules on medical devices and in vitro diagnostics

Read the full position statement.

On Friday, March 21st, the iCARE4CVD Consortium submitted input to the European Commission’s consultation and call for evidence on the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Personalised medicine has been an EU priority since 2015, yet its integration into clinical practice remains limited. Our submission highlights key gaps in the current regulations that hinder innovation in personalised medicine for cardiovascular diseases (CVD).

iCARE4CVD advocates for clearer definitions and pathways for clinical decision support tools and other solutions to ensure that people living with CVD—Europe’s leading health challenge—can benefit from innovative, tailored care.

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