欧盟：MDCG 2025-6：医疗器械人工智能监管新动向（英文版）

This document has been endorsed by the Artificial Intelligence Board (AIB) and the Medical Device Coordination Group (MDCG) established by Article 65 of Regulation (EU) 2024/1689 and Article 103 of Regulation (EU) 2017/745. Both groups are composed of representatives of all Member States and are chaired by a representative of the European Commission MDCG and a Member State (AIB). The document is not a European Commission document and it cannot be regarded as reflecting the official position o