AI
• EU AI Act 2024/1689
• UK, USA, and Canada on AI – Guiding Principles
• FDA – Evaluation Methods for Artificial Intelligence (AI)-Enabled Medical Devices
• FDA – Transparency for Machine Learning-Enabled Medical Devices

IVDs
• FDA – Laboratory Developed Tests: Small Entity Compliance Guide
• MDCG 2020-16 Rev.3 Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
• Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860

Specific Tests
• ISO 5910:2024 Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
• IEC 80601-2-78:2019+AMD1:2024 Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Other
• MDCG 2021-5 Rev.1 Guidance on standardization for medical devices
• MDCG 2024-10 Clinical evaluation of orphan medical devices
• EU REACH Substances of Concern updated list

New Notified Bodies for EU MDR
• TUV SUD Denmark
• AFNOR
• MTIC InterCert Italy
• Kiwa Istanbul
• MS Services GmbH Austria