Leiden University Scholarly Publications

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Hoogervorst, L.A. (2025)

Safety and performance of high-risk medical devices: the role of real-world data

Doctoral Thesis
High-risk implantable medical devices such as hip and knee implants are essential for clinical care. Internationally, the use of real-world data sources to assess safety and performance of high-risk medical devices has increased in recent years as shown by the increased number of publications using registry and administrative data sources, aiming to strengthen the evidence of these medical devices. Real-world data have the advantage of typically including all (i.e. unselected) patients receiving a medical device rather than a selection of patients as enrolled in clinical trials.1 Despite the increase of supporting evidence on performance of medical devices on the market, safety incidents relating to high-risk medical devices still occur.2-5 This raises uncertainty on the quality standards applied for approving these high-risk medical devices for market access.6
The aim of this thesis was to investigate how real-world data of implantable high-risk medical devices – particularly...Show moreHigh-risk implantable medical devices such as hip and knee implants are essential for clinical care. Internationally, the use of real-world data sources to assess safety and performance of high-risk medical devices has increased in recent years as shown by the increased number of publications using registry and administrative data sources, aiming to strengthen the evidence of these medical devices. Real-world data have the advantage of typically including all (i.e. unselected) patients receiving a medical device rather than a selection of patients as enrolled in clinical trials.1 Despite the increase of supporting evidence on performance of medical devices on the market, safety incidents relating to high-risk medical devices still occur.2-5 This raises uncertainty on the quality standards applied for approving these high-risk medical devices for market access.6
The aim of this thesis was to investigate how real-world data of implantable high-risk medical devices – particularly from arthroplasty registries and safety notices – can be used to i) ensure high-quality evidence regarding safety and performance of high-risk medical devices, and ii) develop methods to evaluate the safety and performance of high-risk medical devices. In this chapter, the main findings across all studies of this thesis are summarised with respect to these two aims, the implications of our findings for clinical and regulatory practice are discussed, and recommendations for future practice and research are given.
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Medical devices
Orthopaedics
Hip arthroplasty
Knee arthroplasty
European Medical Device Regulation
Real world data
All authors
Hoogervorst, L.A.
Supervisor
Nelissen, R.G.H.H.; Marang- van de Mheen, P.J.
Committee
Cannegieter, S.; Schalij, M.; Pedersen, A.; Melvin, T.
Qualification
Doctor (dr.)
Awarding Institution
Faculty of Medicine, Leiden University Medical Center (LUMC), Leiden University
Date
2025-11-18