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.