The European Parliament has published the „Regulation of the European Parliament and of the Council amending regulation (EU) 2017/746“.

 This document considers the transitional provisions for (specific) in vitro diagnostic #IVD medical devices, and the altered conditions for application for in-house devices. The 12 page document provides an overview of the changes that will affect the majority of IVD manufacturers seeking eventual IVDR certification, specifically Article 1, 2, 3 and 4 for specific details.

🔗 Original Document :  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CONSIL%3APE_79_2021_REV_1&qid=1643140591226