Medical device CE marking

MedTech Europe issues 2nd edition of the Clinical Evidence Requirements for CE certification under the IVDR

2021-12

The “Clinical Evidence Requirements for CE certification under the In vitro Diagnostic Regulation in the European Union” (First Edition May 2020, Second Edition November 2021) is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVD Regulation 2017/746.

The document can be downloaded in our library

Source: MedTech Europe