EUROPE, 26 DEC 2025 – The European Commission has released a draft Implementing Regulation to amend Annex VII, aiming to introduce maximum timelines and “clock-stops” for conformity assessments under MDR/IVDR. In response, Team-NB (The European Association of Medical Devices Notified Bodies) has published a detailed Position Paper evaluating these changes:click here, While Team-NB welcomes the effort to improve predictability, they warn that the current draft contains “unrealistic” deadlines that could compromise the quality of assessments and increase costs for manufacturers.
TIMELINE DISPUTES & PROPOSALS UNDER MDR AND IVDR REGULATIONS BY NOTIFIED BODY
The draft regulation attempts to set strict maximum durations for Notified Body (NB) activities. However, Team-NB argues that these timelines do not account for the complexity of innovative devices or the training needs of NB staff.
The paper highlights the following key disputes regarding the certification clock:
Technical Documentation (TD) Assessment:
- Commission Proposal: 90 days
- Team-NB Counter: 150 days. They argue that 90 days is insufficient for complex devices requiring multiple expert reviewers and limits the ability to train new staff.
Final Decision Making:
- Commission Proposal: 15 days
- Team-NB Counter: 25 days. The current proposal offers no “clock-stops” during this phase, which Team-NB deems restrictive.
Recertification Review:
- Commission Proposal: 60 days
- Team-NB Counter: 100 days. NBs typically require at least 9 months to conduct full recertification; a 60-day review window is viewed as unfeasible.
KEY IMPACTS FOR MANUFACTURERS UNDER MEDICAL DEVICES REGULATIONS AND NOTIFIED BODY REQUIREMENTS
Beyond internal NB timelines, the Position Paper outlines critical changes that will directly impact manufacturer operations and budgets:
Recertification Strategy: Manufacturers will be responsible for monitoring their own certificate expiry dates. Team-NB advises that you must submit recertification applications at least 1 year prior to the certificate expiry date.
Quotation & Cost Transparency:
Travel Costs:
- The draft requires travel costs to be included in initial quotes. Team-NB rejects this, noting that auditor locations are unknown at the quoting stage. Expect quotes to remain “indicative” regarding travel expenses.
- SME Status: Team-NB states that NBs cannot verify SME status (financial turnover) and suggests this should be verified automatically via EUDAMED registration instead
Transition Period:
- The Commission proposed a short 3-month transition period for these new timelines.
- Team-NB is requesting a 12-month transition period to allow both NBs and manufacturers to adapt their processes.
RESOURCES
To understand the full scope of the proposed changes, you can access the source documents below:
- Full Team-NB Position Paper: Team-NB Position Paper on Annex VII – Implementing Regulation Draft
- Related Guidance: Team-NB Position Paper on MDR Application and appropriate surveillance