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...

Ban on inducements in the Dutch medical device industry

CGR Earlier this year in the Netherlands, the Medical Devices Act has been adapted thereby introducing a ban on inducements that are aimed at stimulating the prescription or supply of medical devices. Details on this policy have been published by the Dutch Foundation...