EU MDR Vigilance: The Reporting Clock Starts Differently Every Time

Article 87 of the EU MDR gives manufacturers not one vigilance reporting deadline but three, and which one applies depends on what the incident actually is — not on how long the investigation takes to find out. Teams that build a single complaint-intake timer around the best-known figure, 15 days, discover the gap only after missing the 2-day or 10-day clock on an incident that deserved faster escalation.

What Article 87 actually sets

MDR Article 87 requires manufacturers to report serious incidents involving devices they have made available on the EU market, and to report field safety corrective actions taken in the EU or in a third country. It does not set one deadline for that duty — it sets three, gated by what kind of incident triggered the report. The operative word in every one of them is immediately, with the day count as the outer limit, not the target. Reconciling vigilance timing with the rest of your EU MDR & IVDR compliance program is what keeps the reporting duty from operating as a standalone fire drill.

The trigger, not the countdown, is where teams get it wrong

Complaint-intake teams that treat 15 days as the default and escalate only after a completed investigation confirms causality are reading the regulation backwards. The 10-day clock for death or unanticipated serious deterioration starts once the manufacturer has established the causal relationship or as soon as it suspects one — suspicion is the trigger, confirmation is not a precondition. A signal that looks credible on first triage should start the clock immediately, with the investigation running in parallel, not ahead of it.

• Serious public health threat (2 days). The population-level risk is the trigger — device-specific causality can still be under investigation.
• Death or unanticipated serious deterioration (10 days). A suspected causal relationship starts the clock; the ten-day window is meant for filing the report, not for reaching certainty.
• Every other serious incident (15 days). The default only after the faster two have genuinely been ruled out — not the first assumption on intake.
• Field safety corrective actions. Reported under the same article, before the action commences unless immediate action is required — a separate decision from the incident report itself.

The clock a complaint starts on is a triage decision, not a paperwork formality. Get the triage wrong and the incident report is the one you file late. Why intake procedures need to model all three deadlines, not one

Where the EU and FDA logic actually diverge

Manufacturers running both markets often assume the EU and FDA vigilance clocks share the same logic because both eventually produce a report on a fixed number of days. They don't. FDA's 5-day/30-day medical device reporting framework shortens the clock for a narrow, defined set of triggers — remedial-action necessity or an FDA written request — layered on top of a 30-day default. MDR's three clocks are tiered by the severity of the incident itself: public health threat, death or serious deterioration, and everything else. A complaint that clears the bar for FDA's 30-day default can simultaneously sit inside MDR's 10-day or even 2-day window, and a single global intake procedure that maps one region's trigger logic onto the other will misroute incidents in at least one of the two markets.

What to do now

None of this requires a new vigilance system. It requires an intake procedure that asks the severity question before the timeline question, and a complaint-handling and vigilance process built to route incidents to the correct clock from the first triage call rather than after a full investigation reclassifies one. Reconciling that intake logic with your post-market surveillance program and your PMCF plan is what keeps a single incident from generating three different, uncoordinated response tracks.