This third revision contains several content updates, examples of common manufacturer’s pitfalls, and a significant rewrite of sections on clinical evaluation and post-market surveillance.
Version 3 of this Team-NB Best Practice Guidance was developed after reviewing over 20 best practice guidance documents from individual notified bodies, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers of medical devices.
The guidance lists detailed requirements and expectations for each of the MDR Annex II (Technical Documentation) and Annex III (Technical Documentation on Post-Market Surveillance) sections and subsections. In addition, common pitfalls as observed by notified bodies are provided throughout the entire document. The revised guidance now counts almost 80 pages, of which more than 20 pages are dedicated to clinical evaluation guidance and pitfalls. Finally, more detailed guidance is now provided on the elements to be integrated in a Post-Market Surveillance Plan and a Periodic Safety Update Report for a medical device under MDR.
This Team-NB MDR Technical Documentation Best Practice Guidance is important for all medical device manufacturers. While every notified body may still have some specific requirements and/or expectations, this document provides manufacturers with valuable information on notified bodies’ common expectations for medical device technical documentation, when being submitted by manufacturers.