- Journal
- Année
- 2021
- Pages
- 289-293
- DOI
- 10.5220/0010971800003123
Abstract
Retrospective studies are studies that easily provide data on a population. As the data are already available in the medical records, the collection and analysis of the results is faster. These studies are particularly valuable in the post-marketing clinical follow-up of medical devices. They allow manufacturers to easily and proactively obtain safety and performance data. The regulatory procedures associated with this type of study also appear to be much less burdensome than a prospective study. We propose to illustrate the procedures through a multinational retrospective study conducted in France, England and Ireland.