Vigilance consists of identifying medical incidents and events and carrying out corrective actions related to device safety.
What is market surveillance reporting (Vigilance)?
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.
What are the requirements for Vigilance at MDR?
The new MDR regulation introduces reporting in the event of a significant increase in the frequency or severity of other incidents. Although trend reporting and analysis are new requirements compared to the current directives, they are already required under MEDDEV 2.12-1. In practice, therefore, the Vigilance requirements set out in the new MDR Regulation are not really new, but rather adapt European legislation to current practice. In addition, a new 15-day deadline for reporting all other serious incidents has been introduced, replacing the current 30-day requirement to report all other incidents. There will also be a requirement for Vigilance reports to be sent to the EUDAMED European database and not to individual national competent authorities, as is currently the case.