Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 “Improving implementation of the European CE certification of medical devices
through the harmonisation of Notified Bodies”
Version: 5.1
Date: June 25th 2025
This updated Code of Conduct supports harmonisation and consistency in CE certification under MDR and IVDR.
It covers key elements such as audit duration, technical documentation assessment, unannounced audits, and structured dialogue – all aligned with the latest regulatory and MDCG guidance.