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...

Healthcare Transparency Register concept law

The Netherlands  On 30 April 2019, the concept text for the Healthcare Transparency Register law was presented for consultation. With this concept law, the obligation for suppliers of medicines and medical devices to report financial relationships with healthcare...

Autocontrol and ‘only once-principle’

Belgium The Royal Decree of 15 November 2017 regarding the notification of a materiovigilance contact point and the registration of distributors and manufacturers of medical devices concerns the introduction of a new registration procedure that should limit the...

Guide on Medical Devices Regulations

The Netherlands The European Regulation for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) will fully apply in 2020 and 2022, respectively. This new regulation will have consequences for the marketing authorization of medical devices. The...