A Modular Approach to Combine Postmarket Clinical Follow-Up Studies and Postmarket Surveillance Studies.

Abstract

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.