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Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) or European Medical Device Regulation standardizes the placing on the market, market availability and activation of medical products and their component parts that are intended for human usage. The new regulation, which was established on May 25, 2017, replaces the MDD (93/42/EEC) and AIMDD (90/385/EEC). Based on the MDR manufacturers of medical devices must provide extensive evidence of the safety of the products and their component parts resting upon clinical data.