On October 2025, TEAM-NB published Version 2 of its Position Paper on Changes to Companion Diagnostic Devices under the IVDR 2017/746, Annex IX (5.2).
The paper provides detailed guidance to manufacturers and Notified Bodies on how to determine when a change to a Companion Diagnostic (CDx) requires prior approval and consultation with medicinal product authorities (e.g., EMA or national competent authorities).
Key insights:
- Reportable vs. non-reportable changes — The paper outlines examples of modifications that affect performance, suitability, or intended use, clarifying which require consultation.
- Consultation pathways — Differentiates between initial and follow-up consultations under Annex IX Sections 5.2 (c–f).
- Legacy device management — Highlights that significant changes to legacy CDx devices under IVDR Article 110(3) remove their legacy status, requiring a new conformity assessment.
- Flowchart-based guidance — Provides a structured decision tree to help manufacturers determine consultation needs with medicinal product authorities.
- Shared understanding — The approach reflects alignment between Notified Bodies and EMA on representative examples and expectations.
This position paper enhances transparency and consistency across the conformity-assessment ecosystem, ensuring timely decision-making and continued patient safety.
At Instituto Pedro Nunes, we support CDx developers and IVD manufacturers in evaluating reportable changes, preparing technical documentation, and managing regulatory interactions with Notified Bodies and competent authorities.
Access the document here.