Haemostasis and Thrombosis Centre, Cremona Hospital, Cremona, Italy.
ECAT Foundation (External Quality Control for Assays and Tests), Voorschoten, The Netherlands.
Int J Lab Hematol. 2022 Sep;44 Suppl 1:71-78. doi: 10.1111/ijlh.13936.
On May 26th 2017 the European Parliament and the Council of The European Union adopted the new regulation on in vitro diagnostic medical devices (IVDR)-Regulation EU 2017/746-planned to be applied from May 26th 2022 in substitution to the previous IVD directives (IVDD 98/79 EC). After several health and legal causes due to medical device malfunctions, the European Union (EU) extensively reviewed the previous regulatory, which had remained unchanged since 1998. Aim of the work is to analyse the effects of the new IVDR on the field of haemostasis and thrombosis testing with particular attention to specific clinical conditions. Clinical laboratories will mainly deal with three different situations: (1) Diagnostic test performed with IVDR products used according with clinical indication certified by manufacturers. (2) Diagnostic test performed with certified IVDR products without clinical validation. (3) Diagnostic test performed with reagents classified as Research Use Only (RUO). At present, only few clinical laboratories through different European countries have been prepared to the new IVDR, while many laboratories are not yet aware about crucial aspects of the new process that deeply involves laboratory medicine. In conclusion, each laboratory should be aware of the IVDR certification of the reagents/instruments used in its laboratory. There are several urgent needs regarding IVDR certification: studies about the clinical performance of haemostasis tests, guidelines for LDTs (definition and documentation), internal and external quality controls for the tests recommended/suggested in the guidance/guidelines and finally implementation and/or update of clinical and laboratory guidelines.
2017 年 5 月 26 日，欧洲议会和欧盟理事会通过了新的体外诊断医疗器械法规（IVDR）-欧盟 2017/746 号法规，计划于 2022 年 5 月 26 日取代以前的体外诊断指令（IVDD 98/79EC）。由于医疗器械故障导致了一些健康和法律问题后，欧盟对以前的监管法规进行了广泛审查，自 1998 年以来，该法规一直没有变化。本研究旨在分析新的 IVDR 对止血和血栓形成检测领域的影响，特别关注特定的临床情况。临床实验室将主要处理三种不同的情况：（1）使用制造商认证的符合临床适应症的 IVDR 产品进行的诊断测试。（2）使用经过认证的 IVDR 产品进行的诊断测试，而无需临床验证。（3）使用被归类为仅供研究使用（RUO）的试剂进行的诊断测试。目前，只有少数几个来自不同欧洲国家的临床实验室已经为新的 IVDR 做好了准备，而许多实验室还没有意识到新流程的关键方面，这个流程涉及到实验室医学。总之，每个实验室都应该意识到其实验室中使用的试剂/仪器的 IVDR 认证。IVDR 认证存在几个紧迫需求：有关止血检测临床性能的研究、LDT 的指南（定义和记录）、推荐/建议的测试的内部和外部质量控制，以及临床和实验室指南的最终实施和/或更新。
