The European Commission’s recent proposal, dated December 12, 2025, to amend annex VII and related sections of the EU Medical Device and In Vitro Diagnostic Medical Devices Regulations (MDR and IVDR) has triggered significant concerns among notified bodies. The proposal aims to streamline conformity assessment processes by introducing maximum timelines and “clock stops” for certification activities. However, the notified body association, TEAM-NB, argues that the Commission’s approach overlooks the complex realities of notified bodies.
Commission’s proposed timelines and clock stops
- The Commission’s regulation introduces strict timelines for certification activities:
- Initial Certification: Application Review: 30 days, one clock stop.
- QMS Assessment: 120 days, three clock stops.
- Technical Documentation Assessment: 90 days, three clock stops.
- Final Decision and Certificate Release: 15 days, no clock stops.
- Changes: Assessment of Change Request: 30 days.
- NB Conformity Assessment and Approval for substantial changes: 90 days. A maximum of three clock stops across both steps.
TEAM-NB’s recommendations: harmonised and pragmatic approach
TEAM-NB argues that these timelines are unrealistic, especially for complex devices and small manufacturers, and would not allow sufficient time for staff training. It strongly recommends a harmonised, pragmatic approach, proposing consistent, realistic timelines for each step of the certification process, whether for initial certification or changes. For recertification, TEAM-NB recommends timelines that account for device complexity and multiple certificates with simultaneous expiry dates to reduce administrative burden and improve predictability.
Quotations: transparency and practicality
TEAM-NB supports detailed quotes for initial certification but recommends indicative pricing for estimated costs, as actual costs may vary. Only if costs change significantly, should notified bodies inform manufacturers and provide justification.
The Commission proposal would also require notified bodies to tailor fees to small and medium enterprises (SMEs). This, however, would mean fornotified bodies to assess the manufacturer’s SME status. The association furthermore says that there are several factors influencing conformity assessment costs, which would make it difficult to make reliable upfront estimations of involved costs.
Call for a rethink and collaboration
TEAM-NB urges the Commission to reconsider most of the proposed timelines and adopt a more harmonised, pragmatic approach. The association emphasises the need for realistic timelines, reduced administrative burden, and greater predictability for all stakeholders. In this context, TEAM-NB also issued a position paper, which can be accessed here.
Source: Medtech Insight (an Informa product), Team-NB
