Bank Paul C D, Jacobs Leo H J, van den Berg Sjoerd A A, van Deutekom Hanneke W M, Hamann Dörte, Molenkamp Richard, Ruivenkamp Claudia A L, Swen Jesse J, Tops Bastiaan B J, Wamelink Mirjam M C, Wessels Els, Oosterhuis Wytze P
Department of Pharmacy, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Department of Clinical Chemistry and Hematology, Meander Medical Centre, Amersfoort, The Netherlands.
Clin Chem Lab Med. 2020 Nov 23. doi: 10.1515/cclm-2020-1384.
The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.
体外诊断医疗器械法规（IVDR）将于2022年5月生效。该法规对体外诊断医疗器械（IVD）制造商和临床实验室都有很大影响。对于临床实验室而言，IVDR对实验室自建检测方法（LDT）的使用提出了限制。为了给临床实践中的同行提供对IVDR的统一解读，荷兰实验室专业科学协会成立了IVDR特别工作组。起草了一份对IVDR相关段落进行解释的指导文件，以帮助实验室为这项新法规的影响做好准备。收集了相关方和利益相关者的反馈意见，并用于进一步完善该文件。在此，我们想向欧洲同行介绍我们的方法，告知他们IVDR的影响，重要的是，我们想介绍一些可能有用的方法，以满足IVDR对LDT的要求。
