Europe
From January 10, 2025, manufacturers of medical devices (MDs) and in vitro diagnostic medical devices (IVDs) placed on the European Union market must report any interruptions or discontinuations in supply when it is reasonably foreseeable that such absence could pose a risk to patient or public health in one or more EU countries.
This obligation applies to all MDs and IVDs (except custom-made devices) where the interruption or discontinuation of supply could result in serious harm or health risks.
Manufacturers are responsible for notifying the competent authority in the country where they are registered. In Belgium, this must be done by completing the relevant form and sending it to shortage.meddev@fagg-afmps.be. While manufacturers can receive assistance from other parties, they remain legally responsible for the notification.
In addition, Manufacturers must inform the economic operators, healthcare institutions, and healthcare professionals who directly receive the device.
Economic operators are then responsible for passing this information down the supply chain to the end user.
This reporting obligation is based on EU Regulation 2024/1860.
Q&A: Q&A – Regulation (EU) 2024/1860 Article 10a MDR and IVDR