Medical Devices Regulation (EU) 2017/745
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On 5 May 2017, two new Regulations on medical devices were published, and they entered into force on 25th May 2017. The Medical Devices Regulation date of application is from 26th May 2020 meaning compliance is mandatory to be able to place Medical Devices on the European market from this date. In vitro Diagnostic Medical Devices Regulation applies from 26 May 2022.
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