TEAM NB: Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746
Version: 5.0
Date: September 16th 2024
Key changes of this version includes:
· General update of references and terminology.
· Compliance with Medical Device Coordination Group (MDCG) Guidance, Team-NB and NBCG-Med Papers
· Clear requirements for unannounced audits
· Methodology for determining audit duration and Estimation of time needed for technical documentation (TD) assessment
· Detailed explanation of re-certification requirements
· Included examples for Structured Dialogue
· Enforcement changed to complaint / appeal process