Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*

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•  ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies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)