探索医疗器械规则 (EU 2017/745) 关于软件作为医疗器械的规定所造成的障碍
1Faculty of Social Sciences, Riga Stradins University, Riga, Latvia.
JMIR medical informatics
|September 5, 2024
概括
欧盟的医疗器械法规 (MDR) 给软件作为医疗器械 (SaMD) 制造商带来了重大障碍,可能会限制患者获得创新医疗技术并减缓行业的增长.
科学领域:
- 医疗信息学 医疗信息学
- 监管科学 监管科学
- 医疗设备工程 医疗设备工程
背景情况:
- 医疗保健行业正在迅速发展,采用数字解决方案,需要适应性监管框架.
- 医疗器械条例 (EU) 2017/745 (MDR) 引入了影响医疗器械开发和市场准入的复杂要求.
- 制造商,特别是中小企业,面临着MDR合规性的挑战,影响了产品在欧盟的可用性.
研究的目的:
- 探索新的医疗器械法规 (MDR) 对软件作为医疗器械 (SaMD) 的开发,推出和营销所引入的阻碍因素.
- 分析SaMD制造商在MDR框架下遇到的障碍.
- 将MDR与相关法规和指令进行比较.
主要方法:
- 这篇论文采用了叙事审查方法.
- 它专注于识别和分析构成SAMD障碍的因素.
- 包括对相关法规,指令和提案的比较分析.
主要成果:
- 多重处理法规定了复杂的要求,对SaMD制造商,特别是中小企业产生重大影响.
- 这些挑战导致制造商停止生产产品,推迟推出或退出欧盟市场.
- 潜在的后果包括医疗保健质量下降和欧盟创新放缓.
结论:
- 严格的MDR要求对欧盟的SaMD创新和市场准入构成重大障碍.
- 缓解这些影响需要有效的政策校准和利益相关者之间的协作努力.
- 解决这些障碍对于保持医疗保健质量和促进欧盟技术进步至关重要.
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