What medical device vigilance means
Vigilance is the part of post-market surveillance that deals with incidents: identifying, reporting, investigating and acting on serious incidents and field safety corrective actions (FSCAs). Under the EU Medical Device Regulation (EU) 2017/745, vigilance is covered by Articles 87 to 92. For US manufacturers selling in Europe, it runs in parallel with FDA’s medical device reporting under 21 CFR 803, with different definitions, clocks and forms.
Serious incident reporting deadlines
Article 87 sets three deadlines, all running from when the manufacturer becomes aware of the incident and its link to the device:
| Situation | Deadline (MDR Article 87) |
|---|---|
| Serious public health threat | ”not later than 2 days after the manufacturer becomes aware of that threat” |
| Death or unanticipated serious deterioration in health | ”not later than 10 days after the date on which the manufacturer becomes aware of the serious incident” |
| Other serious incidents | ”not later than 15 days after they become aware of the incident” |
Source: MDR Article 87, via Advisera. When unsure whether an event is reportable, manufacturers are expected to report within the deadline rather than wait.
Trend reporting
Article 88 requires manufacturers to report “any statistically significant increase in the frequency or severity of incidents that are not serious incidents” that could significantly affect the benefit-risk analysis (MDR Article 88, via Advisera). This means the PMS plan must define how non-serious incidents and expected side effects are trended, which statistical methods are used, and what thresholds trigger a report.
Trending failures also draw FDA attention in the US. A 2026 warning letter found “no CAPA was initiated as the complaints trend did not meet the escalation criteria” and that the firm “failed to analyze complaints and other sources of quality data” (FDA, Zoll). Thresholds that are never reached can be as dangerous as no thresholds at all.
Field safety corrective actions and notices
When a manufacturer takes action to reduce risk for devices already on the market, such as a recall, modification or updated instructions, it is an FSCA. FSCAs must be reported to competent authorities before they are carried out (except in urgent cases), and users are informed through a field safety notice. The FSN should explain the problem, the risk and the actions users must take in clear language.
What is new in 2026
- New MIR form. Finland’s competent authority states that manufacturers of medical devices and IVDs “must start using the reporting form by May 2026, at the latest,” referring to manufacturer incident report form version 7.3.1 (Fimea).
- EUDAMED vigilance is not yet live. Four EUDAMED modules became mandatory on May 28, 2026, but the vigilance and post-market surveillance module is listed as “in development” (European Commission). The Commission’s EUDAMED Q&A says “The VGL module is not available for voluntary use” and that economic operators “need to continue using the national processes as explained in MDCG 2021-1 Rev. 1 and MDCG 2022-12” (European Commission). It will become mandatory six months after the Commission publishes a functionality notice.
- Simplification proposal. The Commission’s December 2025 proposal to simplify the MDR is still in the legislative process; vigilance rules apply as written until any change is adopted (European Commission).
EU vigilance vs US MDR reporting
| Topic | EU MDR vigilance | US MDR (21 CFR 803) |
|---|---|---|
| Standard deadline | 15 days | 30 calendar days |
| Fastest deadline | 2 days for serious public health threat | 5 work days for remedial action events |
| Death or serious deterioration | 10 days | 30 calendar days |
| Trend reporting | Required for statistically significant increases (Article 88) | No equivalent mandatory trend report; trending expected in QMS |
| Form | MIR form v7.3.1 to national authorities | eMDR (Form 3500A data) |
| Database | EUDAMED vigilance module in development | AEMS replacing legacy systems (FDA) |
US timelines per eCFR, 21 CFR 803.
A vigilance process that works in both regions
- Record awareness dates for every complaint and event across all channels.
- Assess reportability in both systems with documented criteria for each.
- Escalate potential serious incidents immediately to trained vigilance staff.
- Report on time, then investigate and submit follow-up and final reports.
- Trend non-serious incidents with predefined statistical methods.
- Manage FSCAs with authority notification, FSNs and effectiveness checks.
- Link outcomes to CAPA, risk management, PSURs and clinical evaluation.
Vigilance readiness checklist
- Vigilance procedure covers MDR Articles 87 to 92
- Serious incident definitions and examples documented
- 2, 10 and 15-day clocks tracked from awareness
- MIR form v7.3.1 in use
- National reporting routes per MDCG guidance documented until EUDAMED vigilance goes live
- Trend reporting methods and thresholds defined in the PMS plan
- FSCA and FSN templates and approval process ready
- US MDR reporting aligned with EU vigilance decisions
- Vigilance outputs feed CAPA, risk files and PSURs
Check vigilance procedures and reports with evidence
Vigilance procedures must handle two regulatory systems without gaps. AskDona checks vigilance procedures, PMS plans and incident files against EU MDR and FDA requirements or your own checklist, flags missing timelines or inconsistent criteria, and cites the passage behind every finding.
Run a sample vigilance procedure assessment on your vigilance SOP. AskDona shows the evidence; your regulatory team decides.
FAQ
What is medical device vigilance? The system for reporting and acting on serious incidents and field safety corrective actions for devices on the market.
How long do I have to report a serious incident under the EU MDR? 15 days in general, 10 days for death or unanticipated serious deterioration, and 2 days for a serious public health threat.
What is trend reporting? Reporting a statistically significant increase in the frequency or severity of non-serious incidents under Article 88.
Is the EUDAMED vigilance module mandatory? Not yet. It is still in development, and national reporting routes apply (European Commission).
How is EU vigilance different from FDA MDR reporting? EU deadlines are shorter, trend reporting is mandatory, and reports go to national authorities on the MIR form.
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| Advisera: MDR Article 87 | Regulation text reproduction | n.d. | Deadlines |
| Advisera: MDR Article 88 | Regulation text reproduction | n.d. | Trend reporting |
| FDA warning letter: Zoll | Regulator | Apr 30, 2026 | Trending failure |
| Fimea: New MIR form | Competent authority | Jan 7, 2026 | MIR v7.3.1 |
| European Commission: EUDAMED overview | Regulator | 2026 | Module status |
| European Commission: EUDAMED Q&A | Regulator | n.d. | Vigilance module |
| European Commission: MDR overview | Regulator | 2026 | Simplification proposal |
| FDA: AEMS launch | Regulator | Mar 11, 2026 | US database |
| eCFR: 21 CFR 803 | Regulation | Current | US timelines |