New Team-NB Update on Companion Diagnostics Under the IVDR 

Team-NB has released a guidance paper on Companion Diagnostics (CDx), providing clarity on how to interpret significant changes to CDx devices under the In Vitro Diagnostic Regulation (IVDR) 2017/746, specifically Annex IX, Section 5.2. This guidance is essential for manufacturers and notified bodies in determining whether planned modifications to CDx devices require prior approval or additional consultation with the European Medicines Agency (EMA) or other national medicinal product authorities.

You can access the full Team-NB position paper, Changes to Companion Diagnostic Devices Under the IVDR, Annex IX, Section 5.2 That Require Prior Approval by a Notified Body here.

Key Updates of the Team-NB Guidance Paper on Companion Diagnostics

The new Team-NB guidance paper on Companion Diagnostics provides enhanced guidance on determining when changes to companion diagnostic devices require consultation with medicinal product authorities, offering a comprehensive decision-making framework through: 

• Clear categorization of reportable changes requiring prior approval.

• Detailed flowchart for determining consultation requirements.

• Practical examples for different types of device modifications.

• Distinction between initial and follow-up consultations with medicinal product authorities.

Three Categories of Changes 

The Team-NB Companion Diagnostics paper identifies three distinct categories of changes to companion diagnostic devices: 

1. Changes Within the Original Consultation Scope: These changes require follow-up consultation. Examples include updates to analytical parameters, changes in reagent formulation, or adjustments to use limitations. 

2. Changes Outside the Original Consultation Scope: These changes trigger an initial consultation and may necessitate a new conformity assessment. Examples include expanding indications, adding new biomarkers, or extending medicinal product claims. 

3. Changes Not Requiring Consultation: These updates do not require consultation and include changes such as supplier alterations, platform transfers, or shelf-life extensions. 

The guidance also emphasizes that legacy CDx devices—those certified under the IVDD before May 26, 2022—will lose their legacy status if any significant changes occur to their design or intended use. Such updates will require full reassessment and consultation under the IVDR. 

What This Means for Manufacturers 

Manufacturers are responsible for determining whether a change to their CDx device requires regulatory consultation. The decision-making process must be justified, documented, and available for competent authorities upon request.  

The flowchart provided in the position paper offers a practical framework for assessing reportable changes and determining when involvement from medicinal product authorities is necessary. 

MedEnvoy’s Perspective 

At MedEnvoy Global, we view this clarification as a vital step toward achieving greater regulatory consistency across the EU. Our experts closely monitor IVDR developments to help manufacturers effectively adapt their change management and regulatory submission strategies. The new Team-NB update on Companion Diagnostics paper highlights the importance of early engagement with both notified bodies and regulatory partners when planning modifications to companion diagnostic devices. 

How MedEnvoy Can Support You 

MedEnvoy offers expert regulatory support to manufacturers in navigating EU IVDR implementation requirements. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support. Contact us so we can assist you. To learn more specifically about our EU service, click here.