List unavailable medical devices

List unavailable medical devices

Belgium The FAMHP published a section listing 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. The list includes medical devices that are...
Medical devices – turnover declaration

Medical devices – turnover declaration

Belgium As from the start of 2023, a new system for funding market surveillance of medical devices by FAMHP applies. Unlike before, this will no longer be limited to the sale of medical devices to retailers and end users.  All actors that carry out an activity...
Amendment to the GMH Code as of 1 January 2022: cooperation Transparency Register

FAMHP: Update of Web Portal applications

Belgium In anticipation of the European regulations on medical devices and in vitro diagnostic medical devices, the FAMHP has updated the “My company” and “My activities” applications in its web portal. The main changes are: The addition of risk classes from...