EU MDR Vigilance Reporting under Article 87: Serious Incident Deadlines

1. Key takeaways

Under Article 87 of the MDR, manufacturers must report serious incidents and field safety corrective actions through the electronic system referred to in Article 92. The three deadlines are tiered by consequence: other serious incidents — immediately, and no later than 15 days after the date of awareness; serious incidents involving death or an unanticipated serious deterioration in the state of health of the subject, user or other person — immediately, and no later than 10 days after the date of awareness; serious public health threats — immediately, and no later than 2 days after the date of awareness of the threat.

These deadlines leave no room for improvised processes. Companies that reliably meet them share three features: a complaint intake and triage flow that fixes the moment of awareness, a severity decision tree that is applied consistently, and a reporting workflow in which the initial report can be submitted incomplete and completed afterwards rather than held back while internal investigations run.

The 2-day tier is the most demanding in practice, because a serious public health threat is usually recognised under pressure and often affects several markets at once. Companies should know in advance who may declare a public health threat reportable, who signs the submission and how the Article 92 electronic system is accessed outside office hours.

2. Legal basis

The reporting duties and deadlines below come from Article 87 of Regulation (EU) 2017/745, read together with the definitions and Commission guidance cited here.

3. Expert insights

Insight 1: The criterion for the three deadline tiers is the consequence, and the deadline can tighten as facts change.

Articles 87(3) to 87(5) tier the deadlines by the consequence of the event. The MDCG guidance gives a worked example: a serious incident is initially assessed as non-fatal and the 15-day tier applies; the manufacturer later learns that the patient died, and the applicable tier becomes 10 days, counted from the date the manufacturer first became aware of the serious incident. In other words, the clock does not restart when new facts arrive; it only tightens, and the earliest reportability date governs. Companies should build their tracking around that earliest date instead of re-setting timers on every internal update.

Insight 2: Uncertainty is not a reason to delay reporting.

Under Article 87(7), where the manufacturer is uncertain whether an event should be reported, the report must still be submitted within the time limits set in Articles 87(2) to 87(5). Under Article 87(6), the initial report may be incomplete and a full report follows afterwards. Read together, the operational rule is report first and complete later, not investigate first and report when everything is clear. Waiting for a completed internal investigation before filing the initial report is one of the most common and most visible failures in authority audits of vigilance processes.

Insight 3: Deadlines are calculated under the EU general time rules and may exceed the nominal number of days on the calendar.

MDCG 2023-3 Rev.2 applies Regulation (EEC, Euratom) No 1182/71 to the calculation of vigilance deadlines: the period starts the day after the triggering event (Article 3(3)), and where the last day of the period falls on a Saturday, Sunday or public holiday, it extends to the last hour of the next working day (Articles 3(4) and 3(5)). As a result, a nominal 15-day deadline can land on calendar day 17 or 18. Documenting the calculation for each report is part of demonstrating compliance (a practical estimate discipline that auditors expect). The same rules apply to the 10-day and 2-day tiers, so a deadline that looks comfortable on a Friday afternoon may in fact expire on Monday morning.

Insight 4: The definition of serious incident includes events that may have led or could lead to the listed consequences.

Under Article 2(65), a serious incident is an incident that directly or indirectly may have led or could lead to any of the following: the death of a patient, user or other person; a temporary or permanent serious deterioration of health; a serious public health threat. The phrase may have led means that a near miss carrying the potential for a serious consequence must also be reported. The determination should use a counterfactual test: if it cannot be excluded that slightly less favourable circumstances would have led to an outcome under Article 2(65)(a) to (c), treat the event as a serious incident (a practical estimate, following the example logic of the MDCG guidance).

4. Practical recommendations

1. Establish a 24 to 72 hour triage flow for complaint intake, fixing the moment of awareness with timestamps (a practical estimate).
2. Build a severity decision tree that includes the counterfactual test for the may have led formulation.
3. Prepare report templates in advance, including the mechanism for submitting an incomplete initial version first (Article 87(6)).
4. Designate a reporting decision-maker and a deputy, so that reporting is never blocked when the responsible person is on leave.
5. Calculate deadlines under the general rules of Regulation (EEC, Euratom) No 1182/71 and document each calculation.
6. Embed the verification role of the PRRC in the process under Article 15, rather than obtaining a signature after the fact.

5. Verification checklist

Use the checklist below before an audit of the vigilance process; each item corresponds to a requirement discussed above.

• □ A three-tier deadline table has been established (15 days / 10 days / 2 days)
• □ Complaint triage and recording of the moment of awareness are in place
• □ The severity decision tree includes the counterfactual test for the may have led formulation
• □ Mechanism for incomplete initial report plus full follow-up report is in place (Article 87(6))
• □ Reporting decision-maker and deputy have been designated
• □ Deadline calculation follows Regulation (EEC, Euratom) No 1182/71 and is documented
• □ PRRC verification step is embedded in the reporting flow

Regulatory information verified as of 29 October 2026.

GRZAN regulatory support. GRZAN assists medical device manufacturers with post-market compliance in the European Union market under Regulation (EU) 2017/745, covering vigilance reporting under Article 87, field safety corrective action (FSCA) recalls, and responses to competent authority inspections. If you need support with your EU MDR vigilance obligations, contact info@grzanglobal.com.