MDR Classification Rule 11 on software has been revised in response to numerous implementation challenges over the past years. In December 2025, the European Commission proposed a revised version of Rule 11, however, several key terms (inform, drive, risk of causing) remain too open to interpretation, creating legal uncertainty and reducing predictability for both manufacturers and authorities. COCIR therefore proposes alternative wording that addresses these challenges, considering international convergence and following a risk-based approach, while supporting the Commission’s objective of simplification without compromising patient safety.
COCIR recommends a simplified rule that preserves the healthcare-situation reflected in the Commission’s proposal but removes the concept of “confers a clinical benefit,” and the distinction between “inform/drive clinical management” distinction and adds the dimension of “healthcare professional oversight’’. This approach is intended to make the rule more operational and reduce possible divergent interpretations.