The FAMHP now publishes a list of medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 and 2017/746, introduced by the regulation (EU) 2024/1860. In other words, medical devices that are temporarily (interruption) or permanently (discontinuation) absent from the Belgian market and whose unavailability could result in serious harm or a risk of serious harm to patients or public health.
The FAMHP has developed a section listing medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), introduced by the regulation (EU) 2024/1860. These are medical devices and in vitro diagnostic medical devices placed on the market of the European Union and for which that unavailability on the Belgian market could result in harm to patients or public health.
The information in this section is updated in line with available data provided by manufacturers. Manufacturers are obliged to provide the FAMHP with this data, and the information provided is their responsibility. This information is intended for healthcare professionals, patients and supply chain actors (e.g. distributors) wishing to monitor market trends and identify any potential temporary or permanent unavailability of a medical device of interest.
This new section has been developed following the entry into force, of Article 1 of Regulation (EU) 2024/1860 at the beginning of January 2025.
More information
• Unavailability of health products - medical devices
• Obligation for manufacturers to notify interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices
• Article 10bis of regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), introduced by the regulation (EU) 2024/1860