欧盟MDR的传统设备合规性
Legacy devices are the medical devices, active implantable medical devices and in vitro diagnostic devices that are placed in the market with valid certificates issued from Medical Devices Directive (MDD) or Active Implantable Medical Device (AIMD). The valid CE (Conformité Européenne) marking certificates are issued according to Directive 93/42/EEC, Directive 90/85/EEC or Directive 98/97/EC on medical devices. The legacy devices continue to be in market when it meets EU MDR compliance for legacy devices as per set timelines.
REGISTRATION OF LEGACY DEVICES
一份文件“ MDCG 2019-5”在2019年4月在Eudamed中的旧设备注册”解释了Eudamed中传统设备注册的指南。Eudamed是医疗设备的欧洲数据库。根据新准则，旧设备在Eudamed中注册。当与产品有关的严重事件或对其采取任何现场纠正措施时，旧设备的注册是必须的。
- EU MDR188bet金搏宝滚球CE标记认证对于医疗设备声称，医疗设备符合欧盟MDR的一般安全和绩效要求，并且可以合法地放置在欧洲市场上。
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传统设备的新标识符
欧盟MDR对传统设备的合规性描述，传统设备将不具有与先前分配的UDI-DI相同的Eudamed-Di，它与UDI-DI和Eudamed ID相同which is same as UDI-DI.
A NEW GUIDANCE ON EU MDR COMPLIANCE FOR LEGACY MEDICAL DEVICES
The European Commission’s Medical Device Coordination Group (MDCG) ‘s has put forth a new guidance that describes the implementation and application of MDR requirements for legacy devices and the devices placed in the market before 26 may 2021.The MDGC had set up ad hoc task- force for applying transitional provisions to the legacy devices and devices placed in the market before 26 may 2021 mentioned in第120条(3)的监管(欧盟)2017/745 (MDR)
MDGC 2021-25 distinguished medical devices into two categories
- Legacy devices:这些是I级无菌，I类测量，IIA级，IIB，III（医疗设备）或主动植入医疗设备，具有有效的CE证书，并在26之后进入欧洲市场thMay 2021.
- Old devices: these are medical devices which have valid MDD or AIMDD certificates and were in the European market before26thMay 2021.
该指南描述了以下应用的三个重要主题：
- Chapter VII of regulation of EU 2017/745 on medical devices (MDR) to ‘legacy devices’
- 其他欧盟MDR要求“传统设备”
- 欧盟MDR要求“旧”设备
MDR第七章中提出的要求
MDR第七章已列出了适用于旧式设备的市场后市场，市场后监视，市场监视和警惕性的所有相关要求。根据第120（3）条，通知机构应考虑适用于过渡规定的旧设备制造商的适当监视或新要求。旧设备需要根据MDD的分类来满足第85条和第86条规定的要求。在过渡期内，应考虑MDR下的风险类别的更改。为了在过渡性提供期间应用新的MDR，受到AIMDD的主动植入设备被认为是III类。
Article 86 MDR explains the periodic safety update report (PSUR). The manufacturers of legacy devices need to update PSUR according to Article 86 MDR and make PSUR available to competent authorities on request also outside EUDAMED. The notified bodies should check whether the manufacturers have made necessary adjustments according to the new MDR on PMS (post market surveillance) and vigilance. The manufacturers need to make available the PSUR’s to the notified bodies in the manner of surveillance audits so as to allow the notified bodies to verify approved quality system so that the design complies to the certificate issued by the MDD or AIMDD.
OTHER MDR REQUIREMENTS TO ‘LEGACY DEVICES’
In addition to Chapter VII, the other MDR needs to be applied to ‘legacy devices’ only to those whose requirements relate to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices.The manufacturers and importers are generally obliqued to comply with MDR (Articles 10(1) and 13(1) for legacy devices,
The EU MDR guidance on compliance of legacy devices states that MDR requirements that have no relation with post-market surveillance, market surveillance, vigilance, registration of economic operators and devices are not liable to apply to economic operators in respect to ‘legacy devices.
NEW REQUIREMENT FOR OLD DEVICES
根据工作队的说法，MDR要求不适用于旧设备，而是在第93至100 MDR中规定的有关市场监视的权利当局的权利和义务也适用于旧设备。这有助于有效的当局监视设备并符合目前的规则，并且还采取必要的行动对不安全的设备。
结论
MDCG已发布了新的指南，以帮助传统设备的制造商根据MDR在欧盟的市场上放置在MDR之前对其设备进行分类。根据欧盟MDR合规性遗产设备的新指南，旧版设备需要进行遗产设备，需要根据其在MDD而不是MDR中的分类来遵守要求。AIMDD下的主动植入设备应被视为III类设备，其原因是在过渡期内应用MDR要求。根据MDR合规性的要求，传统设备的制造商需要更新定期安全更新报告（PSURS）。在审计期间，需要向通知机构和主管当局提供这些报告。对于较旧的设备，即2021年5月26日之前放置在市场上的设备，尽管该指南不适用于旧设备，但是主管当局需要检查设备与目前适用的规则的合规性。MDR合规性涵盖的医疗设备将需要制定临床评估报告（CER）或进行临床调查，以便在设备的CE标记后保持最新。188bet金搏宝滚球持有有效MDD CE标记证书的制造商可以继续在欧洲销售其设备，直到证书到188bet金搏宝滚球期或2024年5月。