On Wednesday 6 November 2024, Team-NB is organizing an online training course for medical device manufacturers who want to deepen their understanding of the technical documentation requirements under the MDR regulation.

ECM invites medical device manufacturers to join the “MDR Technical Documentation Training for Manufacturers” to be held online on 6 November 2024, where we will participate as speakers. The event is intended for manufacturers and aims to strengthen collaboration between Notified Bodies and companies, addressing key topics of Regulation (EU) 2017/745 and providing practical guidance to optimize the preparation of technical documentation.

A COURSE LED BY INDUSTRY EXPERTS

The course, organized by Team-NB with the involvement of professionals from 9 Notified Bodies, including ECM, provides a comprehensive overview of the MDR guidelines and requirements concerning technical documentation. Participants will also have the opportunity to engage directly with leading experts and receive clarifications on common issues.

BENEFITS FOR MANUFACTURERS AND NOTIFIED BODIES

By adopting the best practices shared during the course, manufacturers can submit clearer and more complete technical documentation, thereby reducing the risk of non-conformities and optimizing the evaluation process by Notified Bodies. An informed and effective approach ensures efficient management of approval timelines, offering mutual advantages in terms of both time and resources.

HOW TO PARTICIPATE

The program includes four sessions dedicated to the structure and requirements of MDR technical documentation, focusing on the Technical File (TF) construction and management of General Safety and Performance Requirements (GSPR), post-market surveillance (PMS), and clinical data. Each lesson will be followed by a Q&A session.

Date and time: Wednesday, November 6th, 2024 – 9:00-17:00 CET, online

Participants: limited to 50 organisations, with priority for SMEs registration until October 4th.

Download the flyer here with all the information on how to attend.