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, notifiedbodies, economic operators, health institutions and other relevantparties in order to fight the COVID-19 pandemic and the currentlimited capacity of notified bodies, and taking into account thecomplexity of Regulation (EU) 2017/746, it is very likely thatMember States, health institutions, notified bodies, economicoperators and other relevant parties will not be in a position toensure the proper implementation and full application of thatRegulation from 26 May 2022 as laid down therein.
鉴于当前挑战的规模空前，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全面应用其中规定的 2022 年 5 月26 日。
原文：In order to ensure the smooth functioning of the internalmarket and a high level of protection of public health and patientsafety, as well as to provide legal certainty and avoid potentialmarket disruption, it is necessary to extend the transitionalperiods laid down in Regulation (EU) 2017/746 for devices coveredby certificates issued by notified bodies under Directive98/79/EC.For the same reasons, it is also necessary to provide asufficient transitional period for devices which are to undergoconformity assessment involving a notified body for the first timeunder 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安全的高度保护，以及提供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 shou次接受指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 diagnosticmedical devices that are to undergo conformity assessment involvinga notified body for the first time under Regulation (EU) 2017/746should differentiate between higher and lower risk devices. Thelength of the transitional period should depend on the risk classof the device concerned so that the period is shorter for devicesof a higher risk and longer for devices of a lower risk class.
因此，根据法规(EU) 2017/746 shou次接受指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。
IVDEAR主要承接新冠试剂盒前瞻性临床试验，奥密克戎BA.1和BA.2的临床性能评估，IVDR CE,IVDR技术文件辅导，英国CTDA，澳大利亚TGA，欧盟HSC CommonList，英代服务，欧代服务等服务。
