Exploring the Relationships Between the IVDR and the IVDD

By NSF International, Medical Devices

This tool clarifies the corresponding relationships between the general safety and performance requirements, as defined in Annex I of the EU in-vitro diagnostic medical device regulation 2017/746 (IVDR) and the Essential Requirements defined in Annex I of the EU Directive 98/79/EC for in-vitro diagnostic medical devices (IVDD).

Use this tool to ensure that your in-vitro diagnostic medical devices satisfy all the applicable general safety and performance requirements to demonstrate conformity with the IVDR.

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