OJ:L_202600193: Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications
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⚠️ 风险分析 中
摘要：欧盟更新多项医疗器械协调标准，涉及神经外科植入物、生物评估、临床研究等关键领域。
影响：中国出口至欧盟的医疗器械制造商需及时跟进新标准，否则产品可能因不符合最新要求而面临市场准入障碍。
建议：立即审查并更新产品技术文件，确保符合欧盟最新协调标准，以维持市场准入资格。
「素履以往」
Not the sharpest mind, but the steadiest hand.
Not the sharpest mind, but the steadiest hand.