Vigilance reporting under the EU MDR is a cornerstone of patient safety, aimed at ensuring timely detection, analysis, and correction of serious hazards related to medical devices on the EU market.
What Is Vigilance Reporting?
Vigilance reporting is the systematic process of identifying, documenting, and reporting serious incidents and field safety corrective actions (FSCAs) involving medical devices that are already on the market. The aim is to detect and prevent recurrence of adverse events, ensuring continuous protection of patients, users, and third parties.
In essence, vigilance acts as an early warning system—helping authorities and manufacturers take corrective or preventive actions promptly.
Legal Basis under EU MDR
Manufacturers are required to:
- Report serious incidents and FSCAs to the Competent Authority via EUDAMED.
- Investigate incidents, assess root causes, and document corrective actions.
- Maintain post-market vigilance procedures as part of their Post-Market Surveillance (PMS) system.
What Triggers a Vigilance Report?
A vigilance report must be submitted when any of the following occurs:
- Serious injury: Permanent impairment or medical/surgical intervention needed to prevent it.
- Death: Fatal outcome potentially related to device malfunction or use error.
- Field Safety Corrective Action (FSCA): A corrective action implemented to prevent or reduce a risk to health (e.g., device recall, labeling update).
- Serious public health threat: An incident that may pose widespread or unpredictable risks to the population.
Importance of a Vigilance System
An effective vigilance system helps:
- Identify safety trends and emerging risks.
- Improve device design and labeling through feedback.
- Ensure transparency and regulatory trust.
- Protect patient safety and uphold manufacturer reputation.
Vigilance reporting isn’t merely a compliance exercise — it’s a critical component of a proactive safety culture.
Best Practices for Manufacturers
To maintain compliance and efficiency, manufacturers should:
- Establish clear internal vigilance procedures aligned with Article 87–92.
- Train employees to recognize and escalate potential reportable incidents.
- Integrate vigilance with risk management and post-market surveillance activities.
- Document every vigilance-related activity in a traceable, auditable format.
Vigilance reporting under the EU MDR ensures that safety doesn’t stop at market approval — it continues through constant monitoring, reporting, and improvement. For manufacturers, maintaining a robust vigilance system is both a regulatory obligation and an ethical responsibility to protect patients and sustain trust in medical technologies.
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/
Stay informed, stay compliant!