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.

中文翻译：

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欧盟医疗器械法规的最新监管发展及其对生物材料转化的影响


随着更复杂的生物材料的出现，我们设想这项工作将帮助研究人员和医疗器械开发商（除了其他利益相关者）更好地了解欧盟新 MDR 和 IVDR 提出的基于生物材料的医疗器械开发及其审批流程，MDR 反映了生物材料发现的进展。此外，监管法律的国际协调不足和数据报告质量差也导致了这一问题。本综述描述了过去几十年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器械转化为临床的可行方法。该领域尚未提供将生物材料转化为临床的合适解决方案：不应为研究人员、临床医生、医疗器械行业和保险公司设置额外的障碍，他们都应该合作为患者带来创新解决方案。新的 MDR 和 IVDR 代表了在确保患者安全方面取得的重大进步，反映了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器械开发的创新。将患者安全的逆向工程和“安全设计”（SbD） 策略尽早纳入医疗器械开发，可能会使审批流程更加顺畅和成功。一个坚实的研发阶段，重点是设备安全性和性能评估，是确保有效过渡到临床的基础。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转变范式。 随着更复杂的生物材料的出现，需要适当的法规来继续为患者提供安全和性能良好的医疗解决方案。