COCIR, the European trade association for medical imaging, radiotherapy, health ICT, and electromedical industries, argues that the European Commission’s December 2025 proposal to revise MDR Rule 11 on medical device software risks ambiguity and inconsistent classification. The position paper proposes a simpler framework based on healthcare professional oversight rather than the inform/drive dichotomy and recommends removing the 'confers a clinical benefit' clause. It outlines two variants, favors a no-Class-III option, and urges alignment with current IMDRF thinking while preserving patient safety and market access.
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