Publication Second Edition – Clinical Evidence Requirements for CE certification under the In Vitro Diagnostic Regulation in the European Union

Posted on 02.12.2021

We are pleased to announce the publication of the Second Edition of “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” Regulatory eBook2 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.