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

Recentes

• Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 2)
• Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies
• UK National Commission into the Regulation of AI in Healthcare
• EMA Article 57 Q&A Version 1.15 (9 September 2026)
• EMA guidance on Electronic product information (ePI) submission during centralised procedures
• EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Device Regulation (2017/746) – Impact on international registrations. Middle East and Africa focus
• IMDRF Document Implementation Report. 1 September 2026
• EU Regulatory News : IVD Classification Rules – MDCG 2020-16 Rev.5