9 Key Changes Introduced by the EU Medical Device Regulation (MDR) 2017/745
The medical device sector is highly regulated due to the risk to patient safety, including serious illness or death, which is posed by defective medical devices and/or devices that do not perform as intended. In Europe, medical devices are regulated by the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) …
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