Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.

Abstract

Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist of items necessary for regulators to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance. A three-round Delphi panel. A task within the Coordina