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Magstim获欧盟医疗器械法规（MDR）认证

发布时间：2025-03-03 08:34:19   来源：本站   点击：7次

Magstim通过严格欧盟医疗器械法规合规认证

　　全面拓展欧盟市场准入

　　英国卡马森郡——(2025年5月16日)——Magstim公司旗下所有经颅磁刺激(TMS)系统近日获得欧盟医疗器械法规(EU MDR)认证，标志着其产品完全符合欧盟严格的医疗器械监管要求。此项认证不仅为Magstim TMS技术铺平了通往整个欧盟市场的道路，更验证了该设备的安全性、临床有效性以及完全满足检测与溯源标准。

　　"欧盟MDR认证是基于科学验证的最严苛认证体系，"Welcony集团首席执行官罗尼·斯托莱克-坎波表示，"作为神经调控领域的开拓者，我们团队始终致力于为脑科学研究与临床治疗开发世界级技术。此次认证将帮助我们扩大服务范围，支持这项拯救生命的重要工作。"

　　欧盟医疗器械法规(EU MDR)全面规范了在欧洲经济区(EEA)销售医疗器械的安全性、性能和质量标准，其取代了原先的医疗器械指令(MDD)。该认证由欧盟成员国指定的独立机构——公告机构颁发。

　　斯托莱克-坎波强调："此认证确保客户可以完全信赖Magstim技术已通过医疗器械领域最严苛的质量检测。特别感谢Welcony内部法规事务、研发和支持团队的全力付出——我们深知这项认证将为全球患者带来福祉。"

　　作为目前唯一集成化TMS技术，Magstim现已成为唯一能使用单一治疗线圈同时治疗重性抑郁症(MDD)、焦虑型抑郁症、强迫症(OCD)和青少年抑郁症的TMS系统。美国FDA近期已批准Magstim Horizon 3.0和Inspire经颅磁刺激系统用于15-21岁青少年重性抑郁症治疗，这项无创、非药物技术将为患者提供更优质的诊疗选择。

　　Magstim Passes Compliance with Strict European Union Medical Device Regulations

　　Expanding Magstim Access to Entire EU Marketplace

　　CARMARTHENSHIRE, United Kingdom – (MAY 16, 2025) – Magstim has been granted EU MDR Certification for all transcranial magnetic stimulation (TMS) systems, demonstrating compliance with strict European Union Medical Device Regulations. This provides a path for Magstim TMS technology to be sold throughout the EU marketplace, and proves that the device is safe, clinically effective and has passed requirements for testing and traceability.

　　“The EU MDR is the most rigorous certification backed by verified scientific knowledge,” said Ronnie Stolec-Campo, CEO, Welcony. “As pioneers of neuromodulation for researchers and clinicians, our team is honoured to build world-class technology to study and treat the brain. This certification allows expanded reach to support this life-saving work.”

　　The European Union Medical Device Regulation (EU MDR) governs the safety, performance, and quality of medical devices sold in the European Economic Area (EEA). It replaced the previous Medical Device Directive (MDD). The certification is issued by a Notified Body, an independent organization designated by an EU member state.

　　“Our customers can be confident that with this certification, Magstim technology has passed some of the most rigorous quality testing in medical devices,” said Stolec-Campo. “The big thank you goes to our internal Welcony teams in regulatory, R&D and support for your commitment to get this across the line—we know this will help people worldwide.”

　　As the only integrated TMS technology, Magstim is now the only TMS system with which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil. The FDA recently cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care.