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Version 3.9 brings significant changes to the implementation of the Master UDI

Version 3.9 brings significant changes to the implementation of the Master UDI, it is essential that you keep up to date to ensure compliance with European regulations

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  • The first harmonised standard under the EU AI Act is here
  • PHARMA PACKAGE : Council adopts new rules for a fairer and more competitive EU pharmaceutical sector
  • HTA Regulation – Commission selects first medical devices for joint clinical assessment
  • PHARMACOVIGILANCE UPDATE | FDA E2B(R3) IMPLEMENTATION GUIDE — OCTOBER 2026
  • updated PIC/S PI 006-4 guideline RECOMMENDATIONS ON QUALIFICATION AND VALIDATION
  • Annual report of the Pharmacovigilance Inspectors Working Group for 2025
  • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
  • ACT EU workplan 2026 – 2027

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