EU IVDR 2025 Update: New Guidance Clarifies Change Requirements for Companion Diagnostics

The Team NB released Version 2 of its guidance on companion diagnostic (CDx) devices under the EU IVDR, focusing on Annex IX, Section 5.2 on 29th October 2025. This updated position paper provides clarity for manufacturers on when changes affecting the performance, suitability, or intended use of a CDx require prior notified body approval. A decision-making flowchart in the Annex helps identify reportable changes and determine if consultation with EMA or national medicinal product authorities is required.

Key Points of the Team NB V2 Update

• Focuses on Annex IX, Section 5.2 of the IVDR, outlining notified body involvement.

• Clarifies when prior notified body approval is required for changes to CDx devices.

• Covers changes affecting performance, suitability, or intended use.

• May require either a new conformity assessment or a supplement to the existing certificate, depending on the notified body’s evaluation.

Decision-Making Flowchart

• The Annex includes a practical flowchart for manufacturers.

• Helps identify and justify reportable changes to the EMA or national medicinal product authorities.

• Supports compliance with IVDR requirements and ensures proper documentation for regulatory review.

Implications for Manufacturers

• Manufacturers should review CDx portfolios for any planned changes affecting performance, intended use, or suitability.

• Engage early with the notified body to determine if a new conformity assessment or certificate supplement is needed.

• Follow the flowchart and guidance to document changes and justify decisions regarding consultation with medicinal product authorities.

External Links

• Team NB Position Paper V2 – Significant Changes to CDx Devices (Oct 2025)  

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