Collecting Clinical Evidence in a Post-Market Setting – Three Success Stories

Jon I. Bergsteinsson

Planning and executing a successful post-market clinical data collection strategy is a challenge, and the lack of examples of how PMCF studies shall be conducted leaves many uneasy. The requirements for clinical evidence vary depending on the device type and classification, but “proactive” remains a keyword within the regulation. This presentation focuses on three different cases of PMCF studies, based on real use cases from manufacturers that have had success with proactive data collection. The goal is to inspire other manufacturers, and provide guidance for implementing a successful post-market data collection strategy under the MDR.