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Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process

Europe process chart Medical Devices Regulation (MDR)In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices, which will soon change under the new Medical Devices Regulation (MDR 2017/745). For a more detailed look at the European regulatory process for medical devices under the MDR, download the chart below.

Chart updated: 23/08/2017