Team-NB Releases Consensus Document on EU MDR Certification Process

On December 18, 2024, Team-NB published the MDR Certification Process Consensus Document, a comprehensive guide designed to support manufacturers in navigating the EU Medical Device Regulation (MDR) under Regulation (EU) 2017/745. This new resource provides a structured and streamlined approach to the certification journey, addressing key phases from pre-application to post-certification.

The document offers practical insights into simplifying critical steps such as device classification, preparation of technical documentation, and conformity assessments. It also emphasizes the importance of ongoing surveillance and audits to maintain compliance, ensuring that manufacturers meet MDR requirements effectively and sustainably.

For manufacturers transitioning legacy devices to MDR or certifying new products, this consensus document is an invaluable tool. It clarifies regulatory expectations and helps streamline processes, reducing potential delays and fostering a faster time-to-market.

By standardizing practices and promoting consistency across the certification process, the Team-NB initiative marks a significant advancement for stakeholders in the medical device industry, ultimately contributing to higher levels of patient safety and regulatory adherence across the EU.