Comparison of market authorization systems of medical devices in USA and Europe

maandag 9 februari 2015 9:00

Medical devices are a group of products varying from relatively simple devices like plasters and wheelchairs to complex equipment like pacemakers and MRI scanners. At the request of the Dutch Health Care Inspectorate, RIVM has compared the market authorization systems for medical devices in the United States of America (USA) and Europe. Based on the comparison of the requirements of both systems, it cannot be concluded that one or the other system leads to safer medical devices on the market.