November 2025 — In a move to clarify regulatory expectations under the In Vitro Diagnostic Regulation (EU IVDR 2017/746), Team-NB has released an updated Position Paper (Version 2, dated 22 October 2025), significantly impacting how Companion Diagnostic (CDx) manufacturers approach product changes.
This guidance sharpens the focus on Annex IX, Section 5.2 of the IVDR, outlining clear pathways for when a change to a CDx requires Notified Body approval and potentially a consultation with the European Medicines Agency (EMA) or national medicinal product authorities.
TEAM-NB POSITION PAPER 2025: KEY TAKEAWAYS
The Team-NB V2 update introduces a practical and structured framework for change management in Companion Diagnostics. At the heart of the guidance lies a decision-making flowchart, categorizing changes into three major types:
1. Changes Requiring Initial Consultation
These are typically major changes outside the scope of the original assessment and include:
- Medicinal product extension affecting the CDx claim
- Addition of a new sample type or patient population
- New mutations backed by clinical outcome data
2. Changes Requiring Follow-up Consultation
These fall within the scope of the original consultation and include:
- New limitations or cross-reactivity in the CDx
- Changes to reagent presentation that impact clinical claims
3. Changes Not Requiring EMA Consultation
Operational or technical updates that do not affect performance or suitability, such as:
- Supplier changes
- Shelf-life extensions
- Platform transfers validated internally
EMA CONSULTATION IVDR AND COMPANION DIAGNOSTICS
Manufacturers are urged to re-examine their CDx product portfolios and proactively engage with their Notified Bodies when considering changes. Here are the key takeaways:
- Early Notification is Key: Any planned change impacting performance, intended use, or suitability must be reported in advance. Notified Bodies will assess whether it triggers a new conformity assessment or a certificate supplement.
- Documentation Obligations: Even when no consultation is deemed necessary, manufacturers must provide robust internal justifications and keep documentation readily available for inspection by competent authorities.
- Legacy Devices at Risk: CDx devices previously approved under IVDD and considered “legacy” must be handled carefully. Significant changes can void legacy status, triggering a full reassessment under IVDR Article 110(3).
NAVIGATING CHANGE CONTROL: A ROADMAP FOR COMPANION DIAGNOSTICS
To assist manufacturers, the Team-NB Annex features a flowchart that simplifies the change evaluation process. This is expected to reduce uncertainty and foster alignment between manufacturers, Notified Bodies, and medicinal product authorities across the EU/EEA.
FINAL SUMMARY
This guidance is part of a broader regulatory trend: increased oversight, transparency, and standardization in how diagnostic devices are regulated, especially those closely tied to therapeutic decisions.
Manufacturers should view this not just as a compliance hurdle, but as an opportunity to strengthen product lifecycle management and improve collaboration with regulators.
For those attending Medica 2025 in Düsseldorf, the Team-NB and partners will be showcasing tools and offering direct consultations to support implementation of the new guidance.