The EU's AI Act: What It Means for the Medical Device Industry
2024年10月9日 · The AI Act sets forth specific obligations for high-risk AI systems, many of which align closely with the conformity assessment procedures already in place under MDR and …
The EU medical device regulation: Implications for artificial ...
2021年3月1日 · The EU Medical Device Regulation (EU MDR) [18], replacing the EU Medical Device Directive [19] as of May 26, 2021, imposes stringent regulatory requirements that need …
欧盟AI法案对医疗器械的影响：合规路线图与实施策略解析 – …
范围界定评估：详细评估产品是否属于AI医疗器械范畴; 技术文档准备：按照Article 11要求建立完整的技术文件体系; 质量体系构建：整合AI特定要求的质量管理体系; 第二阶段（2025年8月2 …
Navigating the EU AI Act: implications for regulated digital …
2024年9月6日 · With the EU MDR’s applicability based on intended use, the interplay of EU MDR and the EU AI Act might become difficult to navigate. This is especially the case in situations …
Changes to AI Systems NOTE: the MDR manufacturer will be considered AI provider under the AIA if the high-risk AI system that is a safety component of the medical device is not placed on …
Medical Device Regulation (MDR) Compliance | Avicenna.AI's Certified AI ...
MDR emphasizes rigorous clinical validation, comprehensive documentation, and continuous performance monitoring, all of which are crucial for AI-driven healthcare solutions. For …
Approval of AI-based medical devices in Europe - vde.com
2024年12月10日 · Special requirements for software as a medical device can be found in the MDR in sections 14.2(d), 14.5 and 17.1 to 17.4 of Annex I Chapter II and these are also …
AI in Medical Devices: EU Compliance with AI Act & MDR
6 天之前 · The MDR emphasizes patient safety, clinical effectiveness, and risk management—principles that align with the AI Act’s risk-based approach to AI governance. …
AI Medical Device Software under EU MDR & IVDR - Decomplix
2024年8月30日 · Revolutionary yet controversial, Artificial Intelligence (AI) or Machine Learning was already present in CE-marked medical device software well before the EU AI Act was …
ChatMDR - AI for the medical device regulation (MDR)
ChatMDR is an augmented version of ChatGPT that has access to the state of the art MDR, MDCGs and standards documents. It’s the AI equivalent of a regulatory affairs expert – one …