IVDR General safety and performance requirements Checklist

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In order for In Vitro Diagnostic Medical Devices to be fully compliant with the new IVDR, they have to meet the ‘’General Safety and Performance Requirements’’ listed in Annex I of the Regulation. Even though having a checklist for proving compliance is not strictly mandatory, such a list is strongly recommendable for IVD manufacturers to have an overview over the devices’ compliance. This very useful tool provides a template that helps drawing up such a list.

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Date of publication: March 2019