Recentes

• 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
• Revised version of EU GMP Annex 19: Reference and Retention Samples
• Evaluation of Therapeutic Equivalence. Guidance for Industry
• FDA Considerations for the Regulation of Generative Al-Enabled Medical Devices: Discussion Paper and Request for Feedback