DuPreez Jacques Andre, McDermott Olivia
College of Science & Engineering, University of Galway, Galway, Ireland.
Expert Rev Med Devices. 2025 Mar;22(3):261-275. doi: 10.1080/17434440.2025.2468787. Epub 2025 Feb 28.
This study investigates how Predetermined Change Control Plans (PCCPs) can support the Software Development Life Cycle (SDLC) of certain Software as a Medical Device (SaMD).
Targeted surveys collected qualitative and quantitative data on the current regulatory change process for SaMD; the use of PCCPs; the potential parameters of PCCPs in terms of technical, clinical, usability, and administrative changes to SaMD; and whether PCCPs could be used more broadly for all SaMDs.
Results indicate that the current regulatory approach is not fit for purpose, specifically regarding fast-moving SaMD or continuous-learning AI SaMD. There was strong support for PCCPs to cover device technology, usability, and administrative changes, while clinical changes had limited support and required further investigation. The EU lags behind the US and now the UK in addressing these challenges and should look to legislate and implement PCCPs to ensure ongoing innovation and investment in digital health technologies.
This work is novel in the gathering of meaningful input from experts, practitioners, and regulatory professionals within the SaMD industry located in the EU, UK, and US on the value and need for PCCPs. This study has implications for practice and policy as it can inform SaMD guidance and legislation.
本研究调查预定变更控制计划（PCCP）如何支持某些作为医疗器械的软件（SaMD）的软件开发生命周期（SDLC）。
有针对性的调查收集了关于SaMD当前监管变更流程的定性和定量数据；PCCP的使用情况；PCCP在SaMD技术、临床、可用性和管理变更方面的潜在参数；以及PCCP是否可更广泛地应用于所有SaMD。
结果表明，当前的监管方法不适用，特别是对于快速发展的SaMD或持续学习的人工智能SaMD。对于PCCP涵盖设备技术、可用性和管理变更有强烈支持，而临床变更的支持有限，需要进一步调查。在应对这些挑战方面，欧盟落后于美国，现在也落后于英国，应考虑立法并实施PCCP，以确保对数字健康技术的持续创新和投资。
这项工作的新颖之处在于从欧盟、英国和美国的SaMD行业内的专家、从业者和监管专业人员那里收集了关于PCCP的价值和需求的有意义的意见。本研究对实践和政策有影响，因为它可为SaMD指南和立法提供参考。
