【奥译言】欧洲医疗器械数据库(Eudamed)启动时间统一定在2022年

2019-11-04 11:21  阅读数:74 标签:

欧盟委员会最近表示,其医疗器械数据库(Eudamed)只有在所有模块的功能完全实现且完成独立审核之后才能运作,因此欧盟委员会决定在2022年5月同时启动医疗器械(MD)和体外诊断医疗器械(IVD)的数据库。

 

针对医疗器械(MD)的数据库延迟两年启动(欧盟委员会重申新的欧盟医疗器械法规(MDR)的施行日期仍然是2020年5月),实际上意味着器械制造商可以推迟将数据输入Eudamed。在Eudamed运作后的18个月内,制造商必须将与投放欧盟市场的器械相关的所有数据输入Eudamed。

 

与当前的Eudamed2数据库(国家主管当局与欧盟委员会之间交换市场监督信息的中央储存库)不同,新Eudamed数据库将包含关于行为者、唯一器械标识(UDI)、公告机构和证书、警戒、临床研究和性能研究以及市场监督的不同模块。

 

欧盟委员会此前发布了一系列有关Eudamed的指南文件:1)Eudamed中需要包含哪些UDI数据;2)器械数据字典;3)遗留器械如何在没有唯一器械标识(UDI)的情况下在Eudamed中进行登记;4)企业如何在Eudamed中登记器械数据元素。欧盟委员会还发布了关于Eudamed数据交换服务的指南文件。

 

Eudamed功能规范(v4.1)已于2019年3月6日发布。



英文原文

Eudamed to Launch in 2022for Both Devices and IVDs

Posted 30 October 2019 | By Zachary Brennan

 

The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022.

 

The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Devices Regulation (MDR) remains May 2020) effectively means that device manufacturers can postpone their entering of data into Eudamed. According to the consultancy Emergo, during an 18-month period after the application of Eudamed, all data related to the devices that manufacturers are placing on the EU market must be entered.

 

Unlike the current Eudamed2 database, which acts as a central repository for information on market surveillance exchanged between national competent authorities and the commission, the new database will contain different modules on actors, unique device identifiers (UDIs), notified bodies and certificates, vigilance, clinical investigations and performance studies and market surveillance.

 

The commission has previously issued guidance on what UDI data need to be included in Eudamed, adevice data dictionary, how legacy devices can be registered in Eudamed without a UDI and how device companies will have to register device data elements into Eudamed. The commission has also released guidance on Eudamed data exchange services.

 

The Eudamed functional specifications (v4.1) also have been public since 7 February.




来源:RAPS

原文链接:https://www.raps.org/news-and-articles/news-articles/2019/10/eudamed-to-launch-in-2022-for-both-devices-and-ivd

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