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Clinical Evidence Requirements for CE certification under the In Vitro Diagnostic Regulation in the European Union

Posted on 04.06.2020

We are pleased to announce the publication of “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union" Regulatory eBook developed by MedTech Europe’s Clinical Evidence Working Group (IVD).

As early as IVDR was made available, our members recognized the need to develop a document to interpret the Regulation’s performance evaluation requirements. This led to the development of multiple Q&As including definitions, examples and references. Following our members' generous support this work is publicly available on our website. We hope manufacturers across Europe and the world can benefit by using this eBook and efficiently transition to the new Regulation in an aligned and consistent manner. This exercise has been successful due to the passion and expertise everyone brought to the table. MedTech Europe would like to thank members involved on all sides, especially members of the Clinical Evidence WG (IVD). We welcome your suggestions and invite you to share this eBook internally and externally, in conformity with the disclaimer.