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Mandatory Reporting for Medical Device Supply Interruptions Starting January 2025
From January 2025, manufacturers must report any discontinuation or interruption of medical device supply that could cause serious harm. An overview of who is responsible and how to report.
Manufacturers are obliged beginning from 10th January 2025 to notify authorities in case of discontinuation or interruption of supply of certain medical devices.
Which devices?
All models or types of devices, placed on the Union market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States. The manufacturer must determine whether it is reasonably foreseeable that an interruption or discontinuation of their device could result in serious harm or a risk of serious harm to patients or public health.
How?
Manufacturer Information Form on interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746).
Provided form to download here.
More info here.
KEY TAKEAWAY
From 10 January 2025, manufacturers must notify authorities of any discontinuation or interruption of supply for medical devices.
Relevant disruption that could reasonably result in serious harm or a risk of serious harm to patients or public health. The manufacturer is responsible for determining foreseeability, and reporting is made using the Manufacturer Information Form set out under Article 10a of Regulation (EU) 2024/1860.
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