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UDI HELPDESK

 

The new UDI Helpdesk is live

The European Commission has launched a new helpdesk to support implementing the requirements introduced by the new Unique Device Identification (UDI) system within the context of the new Medical Device Regulation.

The EU Commission has also issued a lot of videos and some material. This is really a great source if you have some questions on UDI.

News & Trends

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Recentes

  • FDA Examples of Real-World Evidence Used in Medical Device Regulatory Decisions
  • FDA eMDR – Electronic Medical Device Reporting
  •  ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
  • EMA’s ePI Roadmap
  • Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
  • The new CTIS Sponsor Handbook (v6.2, March 2026)
  • New revision of the Q&A document on art. 10(a) interruption of supply published
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)

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