TEAM NB has recently updated their Position Paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746”.
To offer some background to this document, TEAM NB has developed unified best practice guidance to clarify expectations for technical documentation submissions under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. All IVD manufacturers, regardless of device class, must prepare and maintain technical documentation demonstrating conformity with the General Safety and Performance Requirements (GSPRs). This documentation must clearly describe the device’s design, development, and manufacturing processes, and explain how compliance has been achieved. As a living document, it must always reflect the current status of the device—whether for premarket submission or post-market review—and be kept up to date through the manufacturer’s Quality Management System. When submitted to a Notified Body, it must be provided in an acceptable language and structured according to the requirements set out in IVDR Annexes II and III and Article 29.
The updated guidance document can be accessed using the following link
