The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.
据国际标准化组织（ISO）称，更新版将侧重于更严格的risk management approach从关键到上市后临床随访（PMCF）的所有临床研究阶段。
ISO 14155的主要变更将ISO 14791要求的医疗器械风险管理原则应用于所有临床调查实例。
ISO 14155 General Requirements
On a high level,ISO 14155的范围继续涵盖与受试者的权利和安全有关的一般要求；确保临床研究的科学进行和结果的可信度；确定赞助者和临床研究者的责任；支持赞助者、研究者和研究者的医疗器械合格评定工作，监管机构和其他利益相关者。亚博全站官网
ISO 14155新变化
We’ve listed the primary changes below as identified by theISO:
- 包括GCP原则的摘要部分；
- 在可公开访问的数据库中注册临床研究的参考资料；
- Inclusion of guidance with regards to clinical quality management;
- 纳入基于风险的监测；
- 纳入指导统计考虑因素；
- Inclusion of guidance for ethics committees;
- Reinforcement of risk management throughout the process of a clinical investigation (planning to consideration of results);
- 澄清本标准要求对不同临床发展阶段的适用性；
- Inclusion of guidance on clinical investigation audits.
ISO 14155实施时间表
The third edition of ISO 14155 remains in draft form. Given ongoing evaluations, consultations and comment periods, final publication of the updated standard is not anticipated until spring 2019 at the earliest.
ISO 14155对您意味着什么
Manufacturers must clinically evaluate medical devices before those can be placed on the market in Europe. To do so, you must examine clinical data in order to investigate whether the medical device is safe and performing. To gather credible data during the clinical investigations we must to comply with ISO 14155, the medical device directives and local laws, respectively the upcoming EU Medical Device Regulation.
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作者：Judith Koehnen，医疗器械和诊断项目管理总监
