EU Commission 2026 Rev.2 Q&A on Supply Interruption for Medical Devices & IVDs

The European Commission released the 2026 Revision 2 Q&A on obligations to inform authorities in case of supply interruptions or discontinuations for medical devices and IVDs. This update under Article 10a MDR/IVDR clarifies when manufacturers and authorized representatives must notify competent authorities and ensures continued EU market availability. Understanding these requirements is critical for manufacturers managing regulatory compliance and supply continuity.

Key Updates in Rev.2 Q&A (April 2026)

• Expanded Guidance on Indicators (Q9.2): Revision 2 adds notes to clarify which indicators manufacturers should consider when assessing potential supply disruptions.  

• New Decision Tree (Footnote 10): A visual tool now assists in determining if a situation qualifies as an interruption or discontinuation requiring notification.

Impact on Manufacturers and Market Access

• Helps manufacturers perform consistent risk assessments.  

• Supports regulatory compliance while maintaining uninterrupted device supply.  

• Enables proactive engagement with competent authorities to avoid supply gaps affecting patient care.

Compliance Steps for Manufacturers

1. Review the updated Q&A in detail: Rev.2 Q&A April 2026  

2. Utilize the decision tree tool for assessments.  

3. Integrate new indicators into internal risk assessment workflows.  

4. Ensure internal procedures are aligned with Article 10a notification requirements.

Internal links

• Learn more about EU MDR Consulting

• Explore EU IVDR Consulting

External links:

• Official EU Commission Q&A PDF: Rev.2 Q&A 2026  

• Article 10a Decision Tree: Decision Tree Tool