Methods Inf Med 2021; 60(03/04): 116-122
DOI: 10.1055/s-0041-1735165
Short Paper

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

1  Cardio-CARE, Medizincampus Davos, Davos, Switzerland
2  School of Mathematics, Statistics and Computer Science, University of KwaZulu Natal, Pietermaritzburg, South Africa
3  Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
,
Kristin Forßmann
4  Syntellix AG, Hanover, Germany
,
Sabine Konopka
5  Phenox GmbH, Bochum, Germany
,
6  Amedon GmbH, Lübeck, Germany
› Author Affiliations
Funding None.

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.

Note

All relevant data are within the manuscript and its Supporting Information files.


Authors' Contributions

A.Z. supported in the methodology, supervision, writing the original draft, and reviewing and editing of manuscript. K.F., S.K., and K.K. helped in the methodology, and reviewing and editing of manuscript.




Publication History

Received: 09 April 2021

Accepted: 05 July 2021

Publication Date:
27 August 2021 (online)

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