European Commission
Medical Devices Regulation, also known as MDR, is an European Union legislation regulating the placing on the market, making available on the market, or putting into service medical devices for human use and accessories for such medical devices. The Regulation applies to manufacturers, distributors, and procurers of medical devices and required all devices to obtain CE marking. The MDR divides medical devices into different classes based on their intended purpose and their inherent risks. Depending on the risk classification, certain medical devices can be subject to stricter obligations under the MDR. The Medical Device Regulation has been fully applicable since 26 May, 2021.
