Exploring The Relationship Between The IVDR And The IVDD
Source: NSF International
This white paper compares the corresponding relationships between the general safety and performance requirements 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). Download the full paper to learn how to ensure that in vitro diagnostic medical devices satisfy all of the applicable general safety and performance requirements to demonstrate conformity with the IVDR.
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