Team-NB Position Paper on the certification process under Regulation (EU) 2017/746

The Team-NB Position Paper on the certification process under Regulation (EU) 2017/746 aims to provide a harmonized and detailed framework for the submission of applications for certification of in vitro diagnostic medical devices (IVDs) under IVDR, in order to facilitate assessment by notified bodies.

This document covers in particular:

• The main stages of the IVDR certification process, from pre-application to post-certification surveillance;
• Best practices for structuring technical files and ensuring their compliance with notified body expectations;
• A list of documents to be submitted at each phase of the process.

By clarifying the practices generally observed among Notified Bodies, this Position Paper helps manufacturers to better understand the various stages of the IVDR certification process, to structure their dossiers more efficiently, and to ensure that they address the most frequent points of attention.

DOWNLOAD THE TEAM-NB POSITION PAPER