From 10 January 2025, manufacturers of medical devices and in vitro diagnostics (IVDs) must notify the relevant competent authorities and economic operators of any interruptions or discontinuations in the supply of certain devices. Specifically, this obligation concerns medical devices and IVDs whose interruptions or discontinuations can cause serious harm or a risk of serious harm to patients or public health. This applies to all manufacturers, whether based in the EU or not, with the exceptions of custom-made devices.
How to notify the authority in case of interruptions or discontinuations
The manufacturer cannot transfer its responsibility for this task. However, it may seek assistance from its authorised representative, other economic operators, or a third party to carry out the required obligations.
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.
Who and when to inform about the supply interruption
The manufacturer should inform:
- economic operators, health institutions, and healthcare professionals to whom the manufacturer directly supplies the device,
- competent authority of the Member State where the manufacturer or its authorised representative is established.
The notification should be submitted at least six months in advance before the manufacturer has anticipated the interruption or discontinuation. There is no need to inform the authorities and the economic operators in case the manufacturer a) replaces the device with a successor device (with similar intended purpose), b) has a stockpile to serve the demand until the device is available again, or c) receives information from health institutions or professionals that there is no risk related to the supply interruption or discontinuation. Additionally, the obligation applies in cases where the disruption will last more than 60 days.
In December 2024, the European Commission published a Q&A document to clarify different aspects of this obligation implementation.
With MDCG 2024-16, manufacturers have a information form available to use to inform the relevant parties.
Do you need more information on manufacturers’ obligations in Europe? Contact us or write an email to mdlaw@obelis.net.
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