In the existing MDD, the concepts of Vigilance and PMS are hardly distinguishable. In the new MDR regulation there is a very clear distinction between them: Vigilance, which is the identification, reporting and trend-setting of serious medical incidents and the implementation of safety related corrective actions, and Post-Marketing Surveillance (PMS), which is the monitoring of information from various sources used to periodically confirm that the benefits of a device still outweigh the risks.