From 10 January 2025, manufacturers will have to report interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices placed on the European Union market for which it is reasonably foreseeable that such absence from the European market could endanger patient or public health in one or more countries.
From 10 January 2025, manufacturers will be required to report interruptions and discontinuations of supply of medical devices (MDs) and in vitro diagnostic medical devices (IVDs). This reporting is mandatory in specific cases listed below. This obligation is linked to Regulation (EU) 2024/1860.
Which devices are involved?
With the exception of custom-made devices, the obligation applies to all MDs and IVDs placed on the European Union (EU) market for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health in one or more EU countries.
Who is responsible for notification?
Manufacturers are responsible for the notification to their competent authority. If they have their registered office in Belgium, they are asked to complete this form and to send it to shortage.meddev@fagg-afmps.be. The manufacturer may not delegate its legal responsibility for this task, but may be assisted by its authorised representative, other economic operators or third parties in carrying out the required operational tasks.
Anticipated interruptions or discontinuations of supply of a device prior to 10 January 2025 do not have to be reported, even if the interruption or discontinuation occurs after 10 January 2025. However, manufacturers are strongly encouraged to do so.
Who must be informed?
The manufacturer must inform
• economic operators, health institutions and healthcare professionals to whom the manufacturer directly supplies the device. Economic operators, upon receiving the information from the manufacturer or another economic operator, are responsible for sharing the information down the supply chain, through to the end user.
• The competent authority of the Member State where the manufacturer (or its authorised representative) has its registered office must also be informed. The competent authority in Belgium is the FAMHP.
For further information
Notification form
Q&A related to Article 10a and its application
FAMHP webpage (in French)