Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
CIRCABC Remote Audit Analysis (May 2021)
Analysis of remote audit practices conducted via CIRCABC during the COVID-19 pandemic, informing permanent remote audit policies.
Download PDFPosition Paper: Article 117 Substantial Changes and Life Cycle Management
Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.
Download PDFPosition Paper: Remote Audits
Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.
Download PDFPosition Paper: Technical Change Plan (TCP)
Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.
Download PDFList of Online Tools to Check Validity of NB Certificates
Reference document from Team NB supporting Notified Bodies in MDR/IVDR implementation.
Download PDFPosition Paper: Documentation Requirements under Article 117
Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.
Download PDFPosition Paper: Dental Implants
Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.
Download PDFJoint NB Spinal Implant Classification Decision Tree
Decision tree tool for classifying spinal implants under EU medical device regulations, developed jointly by European Notified Bodies.
Download PDFContact List for Certificate Transfer Between Notified Bodies
Reference document from Team NB supporting Notified Bodies in MDR/IVDR implementation.
Download PDFPosition Paper: MDR/IVDR Transition (2018)
Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.
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