Medical device vigilance systems are designed for the notification and evaluation of adverse events. Their primary goal is to enhance the protection and safety of patients and other users by reducing the likelihood of recurrence of adverse events related to the use of any medical device.
What is vigilance reporting?
Article 87 of the EU MDR states that manufacturers must report any serious incidents or field safety corrective actions involving devices made available on the Union market to the relevant competent authorities.
Note: A serious incident means any adverse event that led to death, temporary/ permanent deterioration of health or a public health threat.
What are the factors leading to a vigilance report?
- Death: Device or use error leading to the death of the patient/ user
- Serious Injury: Irreversible harm that requires medical or surgical intervention
- Public Health Threat: An incident that presents a large-scale or unforeseen threat to public health
- Field Safety Corrective Action: Actions taken by manufacturer to reduce risk to patients/ users
When and where to report?
| Jurisdiction | Guidance | Initial reporting timeline | Where to report |
| Europe* | EU MDR Article 87 | 2 days: Serious public health threat 10 days: Death or unanticipated serious deterioration 15 days: All other serious incidents | National portals (ANSM, Swissmedic, BfArM etc)** |
| USA*** | FDA 21 CFR Part 803 | 30 days: Death, serious injury, or malfunction 5 days: if action to prevent significant public health risk | eMDR |
** Until EUDAMED is in place
*** 21 CFR 803.10
How to implement an effective vigilance reporting process?
Efficient vigilance reporting by medical device manufacturers requires a structured, proactive approach that ensures timely detection, evaluation, and submission of adverse events.
✅ Establish a Robust Internal Reporting System
- Implement a clear and accessible process for employees, healthcare providers, and customers to report incidents.
- Train staff regularly on identifying and escalating reportable events.
✅ Define Roles and Responsibilities
- Designate a vigilance officer or team responsible for monitoring, assessing, and reporting incidents.
- Utilize cross-functional team consisting of quality, regulatory, clinical, and customer support teams.
✅ Follow Regulatory Timelines Strictly
- Be familiar with jurisdiction-specific timelines (e.g., 2–10–15 days in the EU, 10–30 days in the US).
✅ Conduct Effective Root Cause Analysis (RCA)
- For every reportable incident, perform a structured RCA to determine if the incident is systemic.
- Use tools like 5 Whys or Fishbone diagrams to guide investigations.
✅ Integrate with CAPA and Risk Management
- Ensure findings from vigilance feed into your CAPA system.
- Update risk management files and, if necessary, take preventive or corrective actions.
✅ Review and Update Procedures
- Regularly review vigilance SOPs to reflect current regulations (EU MDR, FDA 21 CFR Part 803, etc.).
- Include lessons learned from past incidents and audits.
✅ Monitor Trends
- Implement trend analysis for non-serious events (as required under EU MDR Article 88).
- Use this analysis to proactively identify risks before they escalate.
In conclusion, an effective medical device vigilance reporting system is not just a regulatory obligation—it’s a vital component of patient safety and product quality. By streamlining processes, leveraging data, and fostering cross-functional collaboration, manufacturers can respond swiftly to risks, enhance compliance, and build trust with regulators and users alike.
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
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