Implementation of the new EU IVD regulation - urgent initiatives are needed to avert impending crisis
Implementation of the new EU IVD regulation - urgent initiatives are needed to avert impending crisis
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DOI：
10.1515/cclm-2021-0975
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发表时间：
2022-01-01
影响因子：
6.8
通讯作者：
Neumaier, Michael
中科院分区：
文献类型：
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作者：
Cobbaert, Christa;Capoluongo, Ettore D.;Neumaier, Michael
欧盟的实验室医学正处于监管革命的黎明，因为它已经达到了从IVDD 98/79/EC（https：//www.example.com）过渡的尾声eur-lex.europa.eu/legal-content/EN/TXT/? uri=CELEX%3A31998L00 79&qid=1628781352814）到IVDR 2017/746 https：//eur-lex。europa.eu/eli/reg/2017/746.如果没有修订和应急计划，2022年5月实施的IVDR将导致医疗保健行业进入未知的沃茨，因为欧盟监管基础设施准备不足。欧盟委员会没有进行前瞻性风险分析，如果没有发生任何情况，可以预期后果将影响医学测试管道的所有利益相关者，可能严重伤害患者，并可能由于无法获得医学测试而阻止护理人员做出适当的临床决策。最后，它还可能阻碍制造商和学术界开发专业测试，从而阻碍医疗诊断护理的创新。我们在此告知实验室专业人员，诊断供应链的代表性利益相关者和学术界在未满足的临床需求领域开发创新的内部测试的证词即将崩溃。欧洲生物医学联盟欧洲监管事务工作组在欧洲生物医学联盟的保护下采取的步骤将得到强调，以及通过与欧盟委员会对话寻求解决方案。虽然我们认识到IVDR促进了积极的目标，如增加临床证据，监督和透明度，但我们需要确保诊断部门的能力不会因基础设施的不准备而受到损害，同时被迫屈服于日益增长的官僚主义和不支持的结构，不支持其“存在权”。
Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31998L00 79&qid=1628781352814) to IVDR 2017/746 https://eur-lex. europa.eu/eli/reg/2017/746. Without amendments and contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infra structural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its "droit d'exister".