Background The European Medical Device Regulation 2017/745 (MDR) has its date of application in May 2021. This new legislation has refined and expanded the need of manufacturers to have a postmarket surveillance (PMS) system. According to this legislation, a postmarket clinical follow-up (PMCF) plan is also required. Manufacturers of high-risk medical devices are obliged to conduct both PMCF and PMS studies. There is thus the need to generate evidence from clinical data.

Objectives The conduct of several studies for PMS and PMCF can be cumbersome. We therefore aim to present a modular approach to combine PMS and PMCF studies into a single study.

Materials and Methods We extracted the topics listed in the MDR, especially Annex XV, Section 3, the Good Clinical Practice for medical devices (EN 14155:2020, Annex A). In addition, we added topics according to the SPIRIT and the SPIRIT-PRO statement and created a draft clinical investigation plan (CIP).

Results The CIP template is provided as part of the manuscript. The modular concept has passed the required regulatory and legal requirements for one specific study.

Conclusion A modular approach for combining PMCF and PMS studies in a single CIP has been developed and implemented, and it is ready for use. The provided CIP template should enable other researchers and groups to adopt this concept according to their needs.

背景 欧洲医疗器械法规 2017/745 (MDR) 的适用日期为 2021 年 5 月。这项新法规完善并扩大了制造商对上市后监督 (PMS) 系统的需求。根据该立法，还需要制定上市后临床随访 (PMCF) 计划。高风险医疗器械的制造商有义务进行 PMCF 和 PMS 研究。因此，需要从临床数据中生成证据。

目标 对 PMS 和 PMCF 进行多项研究可能很麻烦。因此，我们旨在提出一种模块化方法，将 PMS 和 PMCF 研究合并为一项研究。

材料和方法 我们提取了 MDR 中列出的主题，尤其是附录 XV，第 3 节，医疗器械的良好临床规范（EN 14155:2020，附录 A）。此外，我们根据 SPIRIT 和 SPIRIT-PRO 声明添加了主题，并创建了临床调查计划 (CIP) 草案。

结果 CIP 模板作为手稿的一部分提供。模块化概念已通过一项特定研究所需的监管和法律要求。

结论 在单个 CIP 中结合 PMCF 和 PMS 研究的模块化方法已经开发和实施，并且可以使用。提供的 CIP 模板应该能让其他研究人员和团体根据他们的需要采用这个概念。