A Lean System to Report Supply Interruptions and Discontinuations (Article 10a in EU, RoW)

In July 2024, the European Regulation (EU) 2024/1860 introduced Article 10a into both the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). This new article imposes specific obligations on manufacturers, competent authorities, and economic operators to notify authorities in the event of interruptions or discontinuations in the supply of certain devices—where such supply issues are foreseeably likely to cause, or risk causing, serious harm to patients or public health. These requirements apply from January 2025. While MDCG 2024-16 offers some guidance and provides template forms, significant uncertainty remains.


This interactive panel session aims to explore the requirements and approaches from multiple perspectives—including those of healthcare institutions, manufacturers, notified bodies, and competent authorities. We will discuss existing guidance and examine early implementation experiences, sharing practical strategies for compliance and integrating Article 10a requirements into quality management systems (QMS). We will also explore whether Article 10a effectively addresses device availability concerns, or whether it risks becoming a bureaucratic obligation with limited real-world impact. Additionally, the panel will touch upon notification requirements for supply interruptions and/or discontinuities in other jurisdictions around the world.