Post-market surveillance, vigilance and market surveillance
Section 1 — Post-market surveillance
Article 78 — Post-market surveillance system of the manufacturer
Article 79 — Post-market surveillance plan
Article 80 — Post-market surveillance report
Article 81 — Periodic safety update report
Section 2 — Vigilance
Article 82 — Reporting of serious incidents and field safety corrective actions
Article 83 — Trend reporting
Article 84 — Analysis of serious incidents and field safety corrective actions
Article 85 — Analysis of vigilance data
Article 86 — Implementing acts
Article 87 — Electronic system on vigilance and post-market surveillance
Section 3 — Market surveillance
Article 88 — Market surveillance activities
Article 89 — Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 90 — Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 91 — Procedure for evaluating national measures at Union level
Article 92 — Other non-compliance
Article 93 — Preventive health protection measures
Article 94 — Good administrative practice
Article 95 — Electronic system on market surveillance
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