EU MDR/IVDR Targeted Revisions: The Executive’s Strategic Playbook for the 2026 EU Regulatory Shift
The Commission projects industry-wide cost savings of over €3.3 billion per year, though this estimate has been contested by Team-NB, which argues the assumptions appear unrealistic in light of Notified Body revenues.2,3 the final figure, the focus is shifting toward a more strategic form of oversight.
The European regulatory landscape has ofcially entered a “maturity phase.” On December 16, 2025, the European Commission released its long-awaited targeted revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), a 170-page structural correction (COM[2025] 1023 final) designed to restore predictability and innovation capacity.1
Regardless of
As a full-service MedTech CRO, RQM+ sees these revisions not as a rollback of safety, but as an efort to strengthen the proportionality principles that are already embedded in EU regulations. For executives, the challenge is no longer just meeting the requirement; it is about engineering a strategic operating system that turns these new flexibilities into commercial velocity.
The Accountability Trade-Of: Less Oversight, More bottlenecked market entry.2
However, more proportionate external oversight should not be interpreted as a signal to relax internal controls, as it puts the responsibility for maintaining a culture of quality squarely onto the manufacturer. Aiming for the “regulatory minimum” is a high-risk, highly inadvisable strategy; in an environment of less frequent external review, your internal governance must become your primary defense against liability and recalls.
1. Proportionality: The “Well-Established Technology” (WET) Advantage
The proposal introduces a formal, expanded definition for “Well-Established Technology” (WET), defined as devices with a simple, stable design and a long history of safe use in the EU.1
proportionate to the established risk profile, allowing manufacturers to lean heavily on real-world evidence (RWE) and post- market data rather than new prospective clinical investigations3
For these products, the evidence requirements become more :
• The strategic advisory: RQM+ can help you assess which legacy products qualify for these proportionate requirements; this allows you to reallocate clinical budgets toward higher-growth innovations while maintaining a defensible technical file for your stable portfolio
2. Rule 11 Reclassification: Potential Relief for Software-Enabled Technologies The proposal adapts Classification Rule 11, which governs medical device software (MDSW).3
this rule pushed most patient-management and diagnostic apps into Class IIa or higher. The revision restructures how software classification is determined, though regulatory experts difer on the practical impact.
Some interpret the changes as enabling more MDSW to qualify as Class I (removing the notified body requirement), while others caution that the revised rule may be stricter in certain applications.1,4 against the proposed language rather than assume blanket reclassification:
Manufacturers should analyze their software
• The technical guardrail: For software that does qualify for lower classification, the independent verification provided by a notified body is removed, though the full burden of safety documentation remains, as always, with the manufacturer; RQM+ helps ensure your dossiers are ready to withstand the scrutiny of competent authorities, providing confidence that speed to market doesn’t lead to post-market enforcement actions
Under the current framework,
Responsibility The core of the proposal is a shift toward risk-based surveillance. For many Class IIb and III devices, this means moving away from the five-year recertification cycle, with annual surveillance audits permitted to extend to 24-month intervals when doing so is justified.1
The Commission is explicitly attempting to reduce the administrative burdens that have historically
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