The newly reviewed Team-NB Best Practice Guidance for Submission of Technical Documentation under IVDR (Sept 2025) provides clarity on technical documentation requirements according to the In Vitro Diagnostic Medical Devices Regulation – IVDR (EU 2017/746).
This guidance supports manufacturers in preparing technical documentation under Annexes II and III, helping to:
- ✅ Harmonize expectations across notified bodies;
- ✅ Avoid costly delays and rework through complete, cohesive submissions.
🔍 What’s New in Version 2?
- Stronger alignment with MDCG documents, ensuring harmonized interpretation;
- Updated regulatory expectations in key areas such as Risk Management, Performance Evaluation Reports (PER), and Post-Market Surveillance (PMS);
- A dedicated section on Common Pitfalls, highlighting frequent issues observed in submissions.
At Instituto Pedro Nunes (IPN), we help companies align their submissions with best practices—strengthening compliance and reducing approval risks.