In December 2025, the European Commission proposed a draft Implementing Regulation to amend Annex VII, introducing mandatory maximum timelines and defined “clock-stops” for Notified Body activities under the MDR/IVDR. The objective is clear: increase predictability, streamline processes, and support timely access to medical devices.
Team-NB—the European Association of Medical devices Notified Bodies—welcomes the intent, while cautioning that several elements may be difficult to implement without unintended consequences for quality, capacity, and cost.
Team-NB highlights four recurring risks:
- Complexity & feasibility: different clocks for “initial certification” vs. “changes” add complexity to implementation and monitoring.
- Resource constraints: some deadlines, especially technical documentation assessment and decision-making, are viewed as unrealistic given competency requirements and limited availability of qualified reviewers.
- Operational flexibility: the system must accommodate highly complex and high-risk devices, parallel assessments, and varied NB processes.
- Transition periods: the proposed implementation timelines are considered too short.
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