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

Marion Burland (1) , Thierry Chevallier (2, 3, 4)

1 INM - Institut des Neurosciences de Montpellier
2 BESPIM - Laboratoire de Biostatistique, Epidémiologie clinique, Santé Publique Innovation et Méthodologie [CHU Nîmes]
3 F-CRIN - French alliance clinical trial [Paris]
4 IDESP - Institut Desbrest de santé publique

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.

Mots clés: Massive Database; Real Life Study; Post-Market Clinical Follow up; Medical Device

Domaines: Sciences du Vivant [q-bio]

Marion Burland, Thierry Chevallier. The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices. Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed. Special Session on Dealing with the Change in European Regulations for Medical Devices, Feb 2022, Vienna, Austria. pp.243-249, ⟨10.5220/0010952600003123⟩. ⟨hal-03656831⟩