Vigilance is the regulatory process by which manufacturers report serious incidents and field safety corrective actions involving CE-marked devices to the relevant Competent Authorities. Equivalent obligations apply under FDA's Medical Device Reporting (MDR) regulation in 21 CFR Part 803. Under EU MDR Article 87, serious incidents must be reported no later than 15 days after awareness, within 2 days for a serious public health threat, and within 10 days for death or unanticipated serious deterioration in health. Manufacturers must investigate each incident, cooperate with authorities and report field safety corrective actions before taking them, except in urgent cases. MDCG 2023-3 provides vigilance guidance.

Why it matters

Vigilance feeds back into PMS, risk management, and CAPA. Timeliness of reporting is closely scrutinized by regulators.

Common pitfalls

•Failing to report serious incidents within the stipulated regulatory timelines can lead to significant non-compliance issues, including fines and market access restrictions.
•Incomplete or insufficient investigation of reported incidents can hinder effective root cause analysis and delay the implementation of necessary corrective and preventive actions.
•Not adequately documenting the decision-making process for incident reporting and Field Safety Corrective Actions can create challenges during regulatory audits and inspections.
•Assuming that 'no incidents' means 'no problems' and neglecting proactive post-market surveillance activities, which might uncover potential issues before they escalate to serious incidents.
•Misinterpreting the definitions of 'serious incident' or 'serious public health threat,' leading to underreporting or incorrect classification of events.

Sources

MDCG Vigilance Guidance · European Commission
EUDAMED Public Site · European Commission
FDA MAUDE Database · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.