Team-NB Releases Consensus Document on EU MDR Certification Process

The newly released Team-NB Consensus Document on the EU MDR certification process is a crucial resource for manufacturers navigating the Medical Device Regulation (EU) 2017/745. Published on December 18, 2024, this guide outlines the critical steps of the certification journey, including device classification, technical documentation preparation, and conformity assessments. It provides practical strategies for manufacturers transitioning legacy devices or certifying new products, ensuring compliance with MDR requirements. The document also highlights the importance of ongoing audits and surveillance to maintain regulatory standards. By simplifying processes and promoting consistency, the initiative fosters faster time-to-market, enhances regulatory adherence, and strengthens patient safety across the EU medical device industry.