欧盟医疗器械法规的最新监管动态及其对生物材料翻译的影响

IF 6.1 2区 医学 Q1 ENGINEERING, BIOMEDICAL Bioengineering & Translational Medicine Pub Date : 2024-10-16 DOI:10.1002/btm2.10721
Klaudia M. Jurczak, Torben A. B. van der Boon, Raul Devia‐Rodriguez, Richte C. L. Schuurmann, Jelmer Sjollema, Lidia van Huizen, Jean‐Paul P. M. De Vries, Patrick van Rijn
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引用次数: 0

摘要

我们希望这项工作能帮助研究人员和医疗器械开发人员(以及其他利益相关者)更好地理解基于生物材料的医疗器械开发及其审批流程,欧盟新的 MDR 和 IVDR 提出了更复杂的生物材料,MDR 反映了生物材料发现的进展。此外,监管法律的国际协调性不足和数据报告质量不高也是造成这一问题的原因之一。本综述以欧洲市场为重点,描述了过去几十年来生物材料转化趋势放缓的可能原因,并提出了将基于生物材料的医疗器械转化到临床的可行方法。该领域尚未提供将生物材料转化为临床产品的合适解决方案:研究人员、临床医生、医疗器械行业和保险公司不应再设置额外障碍,他们应通力合作,为患者提供创新解决方案。新的 MDR 和 IVDR 标志着在确保患者安全方面取得了重大进展,是医疗保健领域的一大进步。但是,它们不应限制基于生物材料的医疗器械开发创新。在医疗器械开发的早期阶段,从患者安全和 "安全设计"(SbD)战略出发进行逆向工程,可能会使审批过程更加顺利和成功。以器械安全和性能评估为重点的扎实研发阶段是确保器械有效进入临床的基础。我们概述了欧盟近期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的出现,有必要制定适当的法规,以便继续为患者提供安全、性能良好的医疗解决方案。
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Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation
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.
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来源期刊
Bioengineering & Translational Medicine
Bioengineering & Translational Medicine Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
8.40
自引率
4.10%
发文量
150
审稿时长
12 weeks
期刊介绍: Bioengineering & Translational Medicine, an official, peer-reviewed online open-access journal of the American Institute of Chemical Engineers (AIChE) and the Society for Biological Engineering (SBE), focuses on how chemical and biological engineering approaches drive innovative technologies and solutions that impact clinical practice and commercial healthcare products.
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