Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation

Posted 12 December 2017 By Yvonne Middlefell, FRAPS, RAC

placeholder+image This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.

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Categories: In vitro diagnostics, Medical Devices, Labeling, Submission and registration, Features, Europe, EC

Tags: IVDR, Annex 1, Risk Management

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