Q&A on Article 10a obligation to inform about interruption or discontinuation of supply (Rev.2)

Published: 01 Apr 2026

The Commission's DG SANTE published revision 2 of its Q&A on the Article 10a MDR/IVDR duty to inform competent authorities and health institutions before supply of certain devices is interrupted or discontinued, introduced by Regulation (EU) 2024/1860. It covers who to inform, when, what counts as exceptional circumstances, the reasons to report, and the Manufacturer Information Form (referring to MDCG 2024-16). The document is not formally endorsed by the Commission and is general in nature.

Original title: Rev.2 - Q&A Obligation to inform in case of interruption or discontinuation of supply

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