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MDR/IVDR新动向:欧盟发布两份有关欧洲医疗器械数据库的指南性文件

日期:2019-05-05 16:47:38 来源:奥咨达   【字体:

欧盟医疗器械协调小组(MDCG)本周一(2019年4月15日)发布了两份新文件,解释了遗留器械如何在没有唯一器械标识(UDI)的情况下在欧洲医疗器械数据库(Eudamed)中进行登记,以及企业如何在2021年11月之前在Eudamed中登记器械数据元素。

其中,关于数据元素登记的文件(2页)解释了欧盟医疗器械法规(REGULATION (EU) 2017/745,简称“MDR”)的不同条款在器械登记时间表的表述上存在不一致的情况。

同时,MDCG澄清说明如下:“MDR附录VI第A部分第2节和第B部分中所列的器械数据元素在Eudamed中登记的义务,应自第123条第3款第(e)点所述的日期起施行(即:自MDR施行之日后的18个月起施行,或者,如果Eudamed的功能不能如期完全实现,则自第34条第3款所述的通知发布之日后的24个月起施行)。”这18个月的过渡期意味着数据元素必须在2021年11月之前完成登记,或者,如果Eudamed的功能不能如期完全实现,则必须在2022年5月之前完成登记。

另外一份关于遗留器械登记的文件(共4页,其中2页为附录)解释了MDR第120条第3款没有具体提及遗留器械UDI义务的情况。

因此,MDCG认为,“在没有(基本)UDI-DI的情况下,调整Eudamed设计以允许在Eudamed中登记遗留器械是适当的。这是为了防止第120条第3款对遗留器械在Eudamed中登记的适用性的任何技术限制。”

文件附录对技术问题进行了说明,包括与遗留器械未来在Eudamed中登记有关的基本考虑以及遗留器械在Eudamed中登记的技术实现方式。

附录中提到,“MDR施行后凭借根据相关指令签发的有效证书继续投放市场的遗留器械应在Eudamed中登记,无需基本UDI-DI和UDI-DI。这些器械的登记截止日期显然是第123条第3款第(e)点所述的截止日期:MDR施行之日后18个月(前提是Eudamed的功能能够如期完全实现)。”

但是,如果遗留器械未能在18个月内在Eudamed中完成登记,而在此期间又需要报告严重事件或现场安全纠正措施,MDCG表示,在这种情况下,必须在报告严重事件/现场安全纠正措施时进行登记。

英文原文

EU Device Coordination Group Offers Eudamed Guidance

The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed.

The two-page document on the registration of data elements explains how the text of the Medical Device Regulation (MDR) presents an inconsistency with regard to what different articles within it say.

But the MDCG clarifies that:“The obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)).” That 18-month application date would mean data elements have to be registered by November 2021, or if Eudamed is not functional, May 2022.

The four-page document on the registration of legacy devices, which includes a two-page Annex, explains how Article 120(3) of MDR lacks any specific references to UDI obligations for legacy devices.

Therefore, the MDCG “considers it appropriate to adapt the Eudamed design to allow the registration of legacy devices in Eudamed in the absence of a (Basic) UDI-DI. This is intended to prevent any technical constraint to the applicability of Art 120(3) for legacy device registration in Eudamed.”

The Annex includes a deion of the technical implications and explains basic considerations related to the future registration of legacy devices in Eudamed and technical implementation in Eudamed.

“Legacy devices – covered by a valid Directive certificate - that will continue to be placed on the market after the MDR date of application should be registered in Eudamed without a Basic UDI-DI and UDI-DI. The registration deadlines for those devices is clearly the one referred to in Article 123(3)(e):18 months after the date of application (provided that Eudamed is fully functional on time),” the Annex says.

However, in case a serious incident or field safety corrective action needs to be reported during the 18 months during which the legacy devices have not yet been registered in Eudamed, MDCG says they must be registered at the moment of the serious incident/field safety corrective action reporting.

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