Team-NB's New Code of Conduct: Towards a More Harmonized and Transparent Evaluation
Team-NB has published version 5.1 of its Code of Conduct for Notified Bodies, dated June 25, 2025. This document reinforces the commitment of Notified Bodies (NBs) to quality, integrity and transparency in the conformity assessment of medical devices and in vitro diagnostic medical devices, in accordance with Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
What changes for manufacturers?
Voluntary adherence to the Code of Conduct is a clear sign of the NOs' commitment to a robust, predictable and coherent certification system. For manufacturers, this means:
Greater harmonization between Notified Bodies, reducing variations in documentary requirements and audit times.
Enhanced transparency in the auditing and technical assessment processes.
Clear deadlines for corrective action after non-conformities.
Uniform criteria for the duration of audits and review of technical documentation, based on factors such as complexity of the device, risk, number of sites and maturity of the quality management system.
More effective unannounced audits, with a focus on the complete traceability of critical products and suppliers.
Encouragement of structured dialog with manufacturers before and during evaluation processes, within regulatory limits.
Also noteworthy are new guidelines on recertification, voluntary change of NPO, the use of external experts, subcontracting and the management of conflicts of interest - key aspects for ensuring the continued compliance of devices.
This new Code of Conduct represents a significant effort by Team-NB to improve confidence in the European conformity assessment system, both for the authorities and for international partners.
If you are a manufacturer and want to understand how this new code could impact your certification processes, talk to our experts.
Contact us or read the full document below.
