Article 82 governs reporting of serious incidents and field safety corrective actions (FSCAs): manufacturer must report a serious incident no later than 15 days after becoming aware (10 days where serious incident is unanticipated and likely to result in death or unanticipated serious deterioration; 2 days where serious public-health threat). Article 83 governs trend reporting. Article 84 governs analysis of serious incidents and field safety corrective actions. Article 85 governs analysis of vigilance data at Union level. Article 86 governs electronic system on vigilance and post-market surveillance.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.