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                IVDR延期!IVDR法规重大修订!

                浏览次数: 日期:2021-10-26

                1.提案的理由

                欧洲♂议会和理事会的第 2017/746 号条例 (EU) 为体外诊断医疗器械建立了新的监管框架。新法规 (EU) 2017/746原定于2022年5月26日起取代现行的体外诊断医疗器械指令 98/79/EC,并对该行业进行重大变革。

                原文:The Commission recognises the need to ensure both a high level of safety and performance of devices, and their availability on the EU market. The proposal therefore aims to extend the existing transitional period for devices covered by a certificate issued under Directive 98/79/EC and to introduce tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under Regulation (EU) 2017/746. As, since its outbreak, many health institutions, in particular hospitals, have had to focus all their efforts on dealing with COVID-19, the Commission proposes to also introduce a transitional period for the requirements for devices manufactured and used within the same health institution (‘in-house devices’).

                欧盟委员会意识到需要确保器械高水平的更安全性和性能,以★及它们在欧盟市场上的可用性,因此,颁布该提案旨在延长根据指令98/79/EC颁发证书所涵盖的器械∞的现有过渡期,并为根据法规(EU) 2017/746初次需要经过公告机构的合格评定的器械引入量身定制的过渡期。由于自疫☉情爆发以来,许多卫生机构,特别是医院,投入了所有努力集中在应对COVID-19上,因此,委员会还提议对同一卫生机构制造和使用的设备↘(“厂内器械”)的要求引入一个过渡时期▓。

                2.过渡性规定及延期

                原文:Given the unprecedented magnitude of the current challenges, the additional resources needed from Member States, notified bodies, economic operators, health institutions and other relevant parties in order to fight the COVID-19 pandemic and the current limited capacity of notified bodies, and taking into account the complexity of Regulation (EU) 2017/746, it is very likely that Member States, health institutions, notified bodies, economic operators and other relevant parties will not be in a position to ensure the proper implementation and full application of that Regulation from 26 May 2022 as laid down therein.

                鉴于当前挑战的规模划时代,会员国、公告机构、经济运营商∩、卫生机构和其他相关方需要额外资源以抗击 COVID-19 大流行和公告机构◣目前有限的能力,并考虑到 考虑到法规 (EU) 2017/746 的复杂性,成员国、卫生机构、公告机构、经济运营商和其他相关方很可能无法确保该法规的正确实施和更全应用其ζ中规定的 2022 年 5 月 26 日。

                 

                原文:In order to ensure the smooth functioning of the internal market and a high level of protection of public health and patient safety, as well as to provide legal certainty and avoid potential market disruption, it is necessary to extend the transitional periods laid down in Regulation (EU) 2017/746 for devices covered by certificates issued by notified bodies under Directive 98/79/EC.For the same reasons, it is also necessary to provide a sufficient transitional period for devices which are to undergo conformity assessment involving a notified body for the first time under Regulation (EU) 2017/746.

                为了确保内部市场的平稳运行和对公众健∞康和患者更安全的高度保护,以及提供ω 法律确定性并避免潜在的市场混乱,有必要延长法规(EU) 2017/746中规定的,由公告机构根据指令98/79/EC颁发证书所覆盖器械的过』渡期。出于同样的原因,还需要为↙根据法规 (EU) 2017/746 初次接受选定机构参与的合格评定的器械提供足够的过渡期。

                 

                原文:Therefore, the transitional periods for in vitro diagnostic medical devices that are to undergo conformity assessment involving a notified body for the first time under Regulation (EU) 2017/746 should differentiate between higher and lower risk devices. The length of the transitional period should depend on the risk class of the device concerned so that the period is shorter for devices of a higher risk and longer for devices of a lower risk class.

                因此,根据法规 (EU) 2017/746 初次接受选定机构的合格评定的体外诊断医疗器械的」过渡期应区分高风险和低风险器械。过渡期㊣ 的长短应取决于相关器械的风险等级,对于高风险器▆械的过渡期较短,而低风险器械的过渡期较长。

                即根据产品风险适时制定不同过渡期

                3.原条款补充

                很好10条(Article 110)Transitional provisions修改如下:

                在居二段中,日期“2024 年 5 月 27 日”替换为“2025 年 5 月 27 日”即已获得公告①机构(NB)颁发的List A/B/Self-testing的证书有效期更迟将于2025 年 5 月 27 日失效

                原文:

                Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body,for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body,may be placed on the market or put into service until the following dates:

                (a) 26 May 2025 for class D devices;

                (b) 26 May 2026 for class C devices;

                (c) 26 May 2027 for class B devices;

                (d) 26 May 2027 for class A devices placed on the market in sterile condition.

                根据指令98/79/EC 的合格评估程序不需要选定机构参与的器械,根据该指令在2022年5月26日之前为其起草了符合性声明并且符合合格评定程序的器械以及根据本法规的程序需要公告机构的参与评定的器械,可在下述截止期前投放市场或投入使用:
                (a)2025年5月25日-D类器械;

                (b)2026年5月26日-C类器械;

                (c)2027年5月26日-B类器械;

                (d)2027年5月26日-以无菌状态投放市场的A类器械。

                原文:

                Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025.

                根据98/79/EC指令在2022年5月26日之前合法投放市场的器械可以继续在市场上销售或投入使用,直至 2025 年 5 月 26 日。

                4.总结

                首先要明确的是※:IVDR法规生效的时间仍然是2022年5月26日,生◥效时间没有延后!

                4.1此次修订采用逐步适用IVDR法规要求的方式▼,同时优先考虑高风险体外诊断,将现有受公告机构监管的IVD产品的过渡期延长一年,到2025年5月26日。

                4.2在2022年5月26日之前,所有涉及IVDD Others且投放市场的产品可以←继续销售或使用,直至2025年5月26日。

                4.3在IVDD以及IVDR下均属于低风险的自我符合性声明的器械特指】一些仪器、提取试剂盒等,不在此次延长范围内,仍然需要在2022年5月26日之前获得IVDR CE注册证书。

                4.4企业还需↓要根据法规要求在2022年5月26日建立有关上市后监督、市场监督、警戒、经济运营商和器械注册的要求,将其现有的质量体系更新至IVDR法规要求的质量体系。

                4.5对IVDR过渡期条款的调◤整,避免了 (EU) 2017/745和 (EU) 2017/746规定的过渡期同时结★束,并减轻会员国主管当局、通报机构、制造商、卫生机构和处理医■疗器械和体外诊断的其他机构的压力。