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根据 (EU) 2017/745条例对临床数据的"适当性" - - 一个案例研究和调查

Elisabeth Oltmanns^1,2, Michael D'Agosto^1,3, Folker Spitzenberger^4,5

¹Escentia GmbH, Simeonscarré 2, 32423, Minden, Germany.

Therapeutic innovation & regulatory science

|July 3, 2025

概括

欧洲医疗器械条例 (MDR) 对IIb类器械的足够临床证据缺乏明确性. 这项研究强调了不一致的解释和对非临床数据的标准化指导的需要,以平衡安全和创新.

科学领域:

医疗器械规则医疗器械规则
临床证据要求临床证据要求
欧盟监管事务欧盟监管事务

背景情况:

欧洲医疗器械条例 (MDR) 要求增加医疗器械的临床证据.
关于什么构成IIb类非植入器械的足够临床证据,尚不清楚.
这种模糊性给寻求CE标志的制造商带来了挑战.

研究的目的:

调查新的IIb类器件的临床评估是否可以在没有临床研究的情况下进行.
在临床评估中探索类似的通用设备组数据的实用性.
评估当前的监管环境和MDR要求的解释.

主要方法:

进行了专家采访,与通知机构审查人员进行了采访.
管理了一项调查,以评估监管环境和数据的适当性.
对非临床数据和市场后临床随访 (PMCF) 的分析观点.

主要成果:

通知机构在临床证据方面对MDR的解释不一致.
一些审查者接受非临床数据,而另一些审查者要求临床或同等设备数据.
排除来自同一通用设备组的数据使合规性变得复杂,并可能给标准护理设备的制造商带来负担.
在非临床数据的作用方面存在差异,对比较先进的方法比如in silico模型更喜欢实验室测试.
在临床评估中,人们对市场后临床随访 (PMCF) 在临床评估中的作用提出了不同的看法.

结论:

对于在MDR下对临床数据要求的标准化指导是非常必要的.
对非临床证据在临床评估中的作用需要更清晰的定义.
解决这些差距对于平衡患者安全与医疗器械创新至关重要.
标准化指导将导致欧盟中等风险器件的更可预测和更有效的监管途径.

关键词:

临床数据临床数据临床评估临床评估欧洲医疗器械法规欧洲医疗器械法规医疗器械医疗器械医疗器械中等风险的医疗器械

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