Zens Yvonne, Fujita-Rohwerder N, Windeler J
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Im Mediapark 8, 50670, Köln, Deutschland,
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2015 Mar;58(3):240-7. doi: 10.1007/s00103-014-2112-3.
Medical devices play an important role in both the diagnostic and therapeutic care of patients. The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers.
医疗设备在患者的诊断和治疗护理中都发挥着重要作用。人们希望，尤其是创新性的医疗设备能够有助于改善患者护理。然而，对于在欧盟市场准入框架内或在德国法定医疗保险（SHI）报销流程中能够对其益处进行评估的医疗设备，并无强制要求开展临床研究。众多实例表明，现行的市场准入和SHI系统报销法律框架不足以仅为患者提供那些符合《社会法典》第五卷规定的益处要求和质量要求的检查和治疗方法，即医疗设备。然而，对医疗设备进行有意义的临床试验，即随机对照试验，也是可行的。因此，将对具有较高风险等级的医疗设备进行定期的、与适应症相关的益处评估作为特定医疗设备报销的前提条件，不仅是必要的，而且是可行的。医疗保健系统发展评估咨询委员会2014年的报告包含了一项关于实施此评估的有前景的建议。报告中所描述的监管框架将使患者能够尽快获得安全有效的医疗设备创新产品，同时提高新产品开发和营销的规划可靠性，而制造商经常批评这方面的可靠性不足。
