How do medical device manufacturers meet their vigilance obligations under the MDR?
We build a complete vigilance system for manufacturers of medical devices and in-vitro diagnostics: from incident assessment through timely reporting to the competent authority to field safety corrective actions under the Medical Device Regulation (EU) 2017/745. The most common mistake lies not in the report itself but in the assessment that precedes it: anyone who reviews the reportability too late loses the short deadlines under Art. 87, which start running the moment the manufacturer becomes aware of the incident.
- MedTech
- IVD
Overview
What vigilance requirements does the MDR impose?
Vigilance for MedTech & IVD · MDR (EU 2017/745) Art. 87–92, IVDR (EU 2017/746) Art. 82–87, ISO 14971:2019
Last updated: 2026-06-12
Vigilance under the Medical Device Regulation (EU) 2017/745 is the reactive pillar of the post-market system: the structured response to specific incidents subject to a statutory reporting obligation. The four points at which vigilance processes fail in practice:
- Tiered reporting deadlines under Art. 87: serious incidents within 15 days at the latest, a serious public health threat within 2 days at the latest, death or an unanticipated serious deterioration in a person's state of health within 10 days at the latest after becoming aware.
- Mandatory trend reporting under Art. 88 for statistically significant increases in non-serious incidents or expected side effects, even where no individual case is reportable.
- Field safety corrective actions (FSCA) must be reported to the competent authority under Art. 87, analyzed under Art. 89, and communicated to users via field safety notices (FSN).
- The vigilance system is part of the QM system under ISO 13485:2016 and linked to risk management under ISO 14971:2019; the notified body reviews it during the audit.
Services
How we support you
Building the vigilance system under MDR
SOP set for incident assessment, reporting channels, deadline control, and escalation with defined responsibilities, aligned with MDR Art. 87 et seq. and the QM system under ISO 13485:2016.
Incident assessment & MIR preparation
Structured assessment of causality, severity, and reportability for each event, plus preparation of compliant manufacturer incident reports (MIR) in the current MDCG format.
FSCA coordination & authority communication
Planning and reporting of field safety corrective actions under Art. 87 with subsequent analysis under Art. 89, preparation of multilingual field safety notices, and coordination with the competent authority and notified body.
Trend reporting & signal detection
Building trend monitoring for non-serious incidents under Art. 88 with defined thresholds and integration into post-market surveillance.
Learn more →IVD vigilance under IVDR
Transferring the vigilance obligations to in-vitro diagnostics under EU 2017/746 Art. 82–87, including the specific reporting categories for IVD.
Learn more →How we work together
What it comes down to
Vigilance under the Medical Device Regulation (EU) 2017/745 rarely fails at the report itself and almost always at the assessment that precedes it. The deadlines under Art. 87 run from the moment the manufacturer becomes aware of the incident, not from the completion of internal clarification. This creates a bottleneck in sequence: first the triage must decide whether an event is serious and which of the tiered deadlines applies, then the MIR must be produced, and both together must happen within 2, 10, or at the latest 15 days. Anyone who treats the assessment as a downstream step consumes the deadline before the first sentence of the report is written.
The second bottleneck is the separation of vigilance and post-market surveillance. Reactive vigilance under Art. 87 et seq. and proactive PMS under Art. 83–86 are a connected system: trend reporting under Art. 88 requires that statistically significant increases in non-serious incidents be detected, and this only succeeds with thresholds drawn from risk management under ISO 14971:2019. This is exactly where we come in: we build the vigilance process so that deadline logic, trend thresholds, and the feedback into the PMS plan and technical documentation fit together from the start, instead of surfacing as a gap in the surveillance audit.
Our approach
Our approach
Step
Result
As-is analysis of the vigilance process
Assessment of the existing reporting and evaluation process against MDR Art. 87 et seq., documented gap list with prioritization.
Process and SOP design
Vigilance SOPs with deadline logic, a decision tree for reportability, and escalation rules, integrated into the QM system.
Assessment setup & thresholds
Defined assessment criteria and trend thresholds derived from risk management under ISO 14971:2019.
Reporting & MIR
Timely authority reporting via the designated reporting system, MIR submitted in the valid MDCG format.
FSCA & FSN
Coordinated FSCA, approved field safety notices, and traceable escalation to the authority and notified body.
Integration with PMS
Vigilance data feed into the PMS plan and PSUR under Art. 83–86, with continuous feedback into risk management and the technical documentation.
Common pitfalls
Where projects commonly fail
The reporting deadline is counted from completion of the assessment instead of from awareness.
The deadlines under Art. 87 begin the moment the manufacturer becomes aware of the incident, not only after internal clarification. A sluggish triage consumes the short deadlines before the MIR has even been drafted.
Trend reporting under Art.
88 is overlooked. Manufacturers report individual incidents but do not monitor statistically significant increases in non-serious events. Without defined thresholds, a reportable cluster remains invisible until it surfaces in an audit.
Vigilance is run as a process separate from post-market surveillance.
Reactive vigilance under Art. 87 et seq. and proactive PMS under Art. 83–86 are a connected system; if vigilance runs without feedback into the PMS plan and risk management, a gap arises in the technical documentation.
Field safety notices are translated too late.
FSCA require an FSN in the official languages of the affected member states; missing translations delay the action at exactly the moment the risk is active on the market.
IVD vigilance is equated with MDR logic.
In-vitro diagnostics fall under the separate vigilance obligations of the IVDR (EU 2017/746) Art. 82–87, whose reporting categories differ from the MDR; a one-to-one transfer of the MDR SOPs leads to incorrect reporting decisions.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): primary text, Art. 83–92, in particular Art. 87 (reporting and deadlines), Art. 88 (trend reporting), Art. 89 (analysis of incidents and FSCA)
- Regulation (EU) 2017/746 (IVDR): primary text, Art. 82–87 (vigilance for in-vitro diagnostics)
- ISO 14971:2019: application of risk management to medical devices
- ISO 13485:2016: quality management systems for medical devices
- https://theentourage.de/expertise/medical-device-vigilanz/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR) Art. 87 (reporting of serious incidents and FSCA)
- EU 2017/745 (MDR) Art. 88 (trend reporting)
- EU 2017/745 (MDR) Art. 89 (analysis of serious incidents and FSCA)
- EU 2017/745 (MDR) Art. 90–92 (analysis of vigilance data and electronic system)
- EU 2017/745 (MDR) Art. 83–86 (post-market surveillance)
- EU 2017/746 (IVDR) Art. 82–87 (vigilance for in-vitro diagnostics)
- ISO 14971:2019 (risk management for medical devices)
- ISO 13485:2016 (QM system)
Related topics
Post-Market Surveillance →
The proactive pillar: PMS, PSUR, and PMCF obligations under MDR Art. 83–86
Risk Management →
ISO 14971:2019 provides the thresholds for vigilance assessment and trend
MDR Conformity →
Overall MDR compliance, from classification to certification
Signal Detection →
The signal detection methodology that applies in trend reporting under Art. 88
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