Jurczak Klaudia M, van der Boon Torben A B, Devia-Rodriguez Raul, Schuurmann Richte C L, Sjollema Jelmer, van Huizen Lidia, De Vries Jean-Paul P M, van Rijn Patrick
Biomaterials and Biomedical Technology Department-FB40 University of Groningen, University Medical Center Groningen Groningen The Netherlands.
Department of Surgery, Division of Vascular Surgery University Medical Centre Groningen, University of Groningen Groningen The Netherlands.
Bioeng Transl Med. 2024 Oct 16;10(2):e10721. doi: 10.1002/btm2.10721. eCollection 2025 Mar.
We envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial-based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as more complex biomaterials emerge, with the MDR reflecting the progress in biomaterial discoveries. Additionally, insufficient international harmonization in regulatory laws and poor-quality data reporting contribute to the problem. This review describes the possible reasons for a slowing biomaterials translational trend observed over the past decades, focusing on the European Market, and suggests a feasible approach for biomaterials-based medical device translation into the clinic. Suitable solutions to upgrade biomaterial translation to the clinic have not yet been provided by the field: no additional hurdles should be imposed for researchers, clinicians, the medical device industry, and insurance companies, which all should collaborate on bringing innovative solutions to patients. The new MDR and IVDR represent a substantial advancement in ensuring patient safety and reflect a major step forward in healthcare. However, they should not constrain innovation in biomaterials-based medical device development. Incorporating reverse engineering from patient safety and a 'safe by design' (SbD) strategy early into medical device development might lead to a smoother and successful approval process. A solid R&D phase, with an emphasis on device safety and performance assessment, is fundamental to ensure an effective transition into the clinic. We offer an overview of the recently implemented regulations on medical devices and in vitro diagnostics across the EU, describing a shifting paradigm in the field of biomaterials discovery. As more complex biomaterials emerge, suitable regulations will be necessary to keep bringing safe and well-performing medical solutions to patients.
我们设想这项工作能帮助研究人员和医疗设备开发者（以及其他利益相关者）更好地理解基于生物材料的医疗设备开发以及欧盟新的《医疗器械法规》（MDR）和《体外诊断医疗器械法规》（IVDR）提出的审批流程。随着更复杂的生物材料出现，MDR反映了生物材料发现方面的进展。此外，监管法律缺乏国际协调以及数据报告质量不佳也加剧了这一问题。本综述描述了过去几十年中观察到的生物材料转化趋势放缓的可能原因，重点关注欧洲市场，并提出了一种将基于生物材料的医疗设备转化应用于临床的可行方法。该领域尚未提供将生物材料转化提升至临床的合适解决方案：不应给研究人员、临床医生、医疗设备行业和保险公司设置额外障碍，各方应合作，为患者带来创新解决方案。新的MDR和IVDR在确保患者安全方面取得了重大进展，是医疗保健领域向前迈出的重要一步。然而，它们不应限制基于生物材料的医疗设备开发的创新。在医疗设备开发早期纳入基于患者安全的逆向工程和“设计即安全”（SbD）策略，可能会带来更顺畅、成功的审批流程。一个坚实的研发阶段，重点是设备安全性和性能评估，是确保有效转化应用于临床的基础。我们概述了欧盟最近实施的医疗器械和体外诊断法规，描述了生物材料发现领域的范式转变。随着更复杂的生物材料出现，需要合适的法规来持续为患者提供安全且性能良好的医疗解决方案。
