Coste Alix T, Egli Adrian, Schrenzel Jacques, Nickel Beatrice, Zbinden Andrea, Lienhard Reto, Dumoulin Alexis, Risch Martin, Greub Gilbert
Institute of Microbiology, University of Lausanne & University Hospital Center, 1011 Lausanne, Switzerland.
Institute of Medical Microbiology, University of Zurich, 8006 Zurich, Switzerland.
Diagnostics (Basel). 2023 Sep 11;13(18):2910. doi: 10.3390/diagnostics13182910.
IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes IVDR regulation risky, because its detrimental effect on production of in-house tests will negatively impact knowledge and expertise in the development of new diagnostic tests. Moreover, such regulations negatively impact the availability of diagnostic tests, especially for neglected pathogens, and has a detrimental effect on the overall costs of the tests. The increased regulatory burden of IVDR may thereby pose an important risk for public health. Taken together, it will have a negative impact on the financial balance of diagnostic microbiology laboratories (especially small ones). The already-high standards of quality management of all ISO-accredited and Swissmedic-authorized laboratories render IVDR law of little value, at least in Switzerland, while tremendously increasing the regulatory burden and associated costs. Eventually, patients will need to pay for diagnostic assays outside of the framework of their insurance in order to obtain a proper diagnostic assessment, which may result in social inequity. Thus, based on the risk assessment outlined above, the coordinated commission for clinical microbiology proposes adjusting the IvDO ordinance by (i) introducing an obligation to be ISO 15189 accredited and (ii) not implementing the IvDO 2028 milestone.
体外诊断医疗器械法规（IVDR）对诊断微生物学实验室来说是一项重大挑战。IVDR使众多方面变得复杂，并带来风险，因为病原体种类繁多（包括罕见但高致病性的微生物），且送检分析的样本种类多样。新病原体不断出现（如欧洲在新冠疫情后出现的埃可病毒E - 11、腺病毒41、猴痘病毒、阿龙山病毒和肠道病毒D68），这是使IVDR法规具有风险的另一个因素，因为其对内部检测生产的不利影响会对新诊断检测的开发知识和专业技能产生负面影响。此外，此类法规对诊断检测的可及性产生负面影响，尤其是对被忽视的病原体，并且对检测的总体成本有不利影响。IVDR增加的监管负担可能因此对公共卫生构成重大风险。综合来看，这将对诊断微生物学实验室（尤其是小型实验室）的财务平衡产生负面影响。所有获得ISO认可和瑞士药品管理局授权的实验室本就已经很高的质量管理标准使得IVDR法规至少在瑞士几乎没有价值，同时极大地增加了监管负担和相关成本。最终，患者将需要在保险框架之外支付诊断检测费用，以便获得适当的诊断评估，这可能导致社会不平等。因此，基于上述风险评估，临床微生物学协调委员会提议通过以下方式调整体外诊断医疗器械指令（IvDO）条例：（i）引入获得ISO 15189认可的义务；（ii）不实施2028年的IvDO里程碑。
