IVDR General safety and performance requirements Checklist


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