Exploring the Relationships Between the IVDR and the IVDD

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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