SIS-CEN/TR-17223 › Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
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This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.
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03.100.70 (Management systems Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject Including environmental management systems (EMS), road traffic management systems, energy management systems, health care management systems, etc.)
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March 28, 2018