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This Technical Report provides guidance on the relationship between CEN ISO TR 20416:2020 (Medical devices – Post-market surveillance for manufacturers) and the requirements in the European Regulations on Medical Devices (MDR)- Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746.
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Darbības sfēra
This Technical Report provides guidance on the relationship between CEN ISO TR 20416:2020 (Medical devices – Post-market surveillance for manufacturers) and the requirements in the European Regulations on Medical Devices (MDR)- Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746.
