New e-book about the requirements for CE-certification under the IVDR
MedTech Europe has published a new e-book about the clinical evidence requirements that must be fulfilled to obtain CE certification under the In Vitro Diagnostic Medical Regulation (2017/746) ("IVDR"). The e-book is designed to help manufacturers to better understand and comply with the requirements set out in the IVDR.
The e-book is largely built up as a Q & A and provides a structured guidance as to how different terms and concepts in the IVDR should be interpreted and understood. Terms and concepts as, e.g., "intended purpose", scientific and clinical validity, equivalence and similarity and the different clinical evidence levels, are elaborated, and it is explained how these should be construed and understood.
Further, the e-book offers a practical angle and gives examples on how manufacturers can comply with the requirements in IVDR, e.g. to what extent analytical and clinical performance can be used as components of clinical evidence, the process of post-market performance follow-up and how evidence gained from "published/documented routine testing" can be demonstrated.
Even though the e-book constitutes a qualified opinion on how the IVDR is to be understood, it is essential to note that the e-book reflects MedTech Europe's interpretation of the IVDR.
The IVDR is currently set to come into force on 26 May 2022.
Read the new e-book
Read MedTech Europe's announcement of the publication