Article 10a MDR / IVDR : New guidance documents

The European Commission has published updated reference documents related to Article 10a of the MDR and IVDR, addressing the information obligations in the event of an interruption or discontinuation of supply of medical devices and in vitro diagnostic medical devices.

Article 10a Q&A – Revision 2 (April 2026)
This updated Q&A provides operational clarifications on:

• the situations covered by the information obligation,
• the assessment of the risk of serious harm to patients or public health,
• the timing and modalities of notifications to competent authorities and actors in the supply chain.

Article 10a decision tree
A decision tree now complements the Q&A, supporting manufacturers in a structured and consistent determination of whether notification under Article 10a is required, based on their specific situation.

Together, these documents provide practical tools to strengthen regulatory analysis and anticipate MDR/IVDR information obligations, applicable since 10 January 2025.