The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices

Marion Burland, Thierry Chevallier, Thierry Chevallier, Thierry Chevallier

2022

Abstract

With the application of new European regulations on medical devices in May 2021, the requirements for clinical evaluation have been strongly reinforced. Post-marketing clinical follow-up is now a key activity for manufacturers to keep their medical devices on the market. The use of material-epidemiology studies and real-life databases has multiple strengths and advantages. However, the weaknesses and limitations identified do not yet allow manufacturers (especially small and medium-sized companies) to fully utilize these tools for post-market clinical follow-up. Yet certain technological and regulatory developments already implemented, and to be implemented over time, suggest that these tools could play a crucial role in the clinical monitoring of medical devices in the future. In order to better define the future use of real-life data in post-market clinical follow-up activities, a comprehensive update of technological and regulatory surveillance is still required.

Paper Citation

in Harvard Style

Burland M. and Chevallier T. (2022). The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices. In Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-552-4, pages 243-249. DOI: 10.5220/0010952600003123

in Bibtex Style

@conference{clinmed22,
author={Marion Burland and Thierry Chevallier},
title={The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices},
booktitle={Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2022},
pages={243-249},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010952600003123},
isbn={978-989-758-552-4},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices
SN - 978-989-758-552-4
AU - Burland M.
AU - Chevallier T.
PY - 2022
SP - 243
EP - 249
DO - 10.5220/0010952600003123