Publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook

Posted on 23.02.2023

We are pleased to announce the publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook.

The Questions and Answers eBook was developed by MedTech Europe’s Clinical Evidence Working Group (IVD), which includes IVD experts in regulatory, clinical, and quality fields matters. This Third Edition of the eBook brings in additional examples, improved clarity, better flow, and updated references and diagrams compared to the previous editions.