PhaRegistrum · Originally published on 23/10/2026
The European Commission has published Rev. 2 of the Q&A on the obligation to inform in the event of an interruption or discontinuation of the supply of certain medical devices and in vitro diagnostic medical devices, under Article 10a of the MDR and IVDR.
This update clarifies key points:
- The circumstances that trigger the notification obligation.
- The deadlines and information to be provided.
- The assessment of the potential risk of serious harm to patients or public health.
- The responsibilities of the different operators in the supply chain.
For manufacturers and other economic operators, this obligation highlights the importance of internal processes to identify, assess and communicate potential supply interruptions in good time.
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