Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation

The “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” (First Edition May 2020, Second Edition November 2021, Third Edition February 2023) is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVD Regulation 2017/746.

These questions and answers are the results of the collective wisdom of many regulatory and clinical experts, members of MedTech Europe and authority representatives.

MedTech Europe is committed to supporting the IVD industry in successfully transitioning to the IVD Regulation. This publication is being put in the public domain so that manufacturers both within and outside our membership can efficiently transition to the new Regulation in an aligned and consistent manner.

Please see below the three editions of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” MedTech Europe:

• Third Edition, published February 2023 new
• Second Edition, published November 2021
• First Edition, published May 2020