What are the EU MDR vigilance reporting timelines?

EU MDR Articles 87–90 require manufacturers to report serious incidents to competent authorities within: 15 calendar days (serious public health threat), 10 days (death or serious deterioration), and 30 days (other reportable incidents). FSCAs must be reported immediately.

What is the difference between vigilance reporting and FSCA?

Vigilance reporting covers the notification of serious incidents and trends to competent authorities. A Field Safety Corrective Action (FSCA) is a remedial action taken to reduce risk — it must be communicated via a Field Safety Notice (FSN) and also notified to authorities.

Is vigilance reporting handled by the manufacturer or the EC REP?

The manufacturer is primarily responsible for vigilance reporting. The EC REP may assist in communication with EU competent authorities, but they cannot substitute for the manufacturer's primary responsibility.

Book an EU MDR Vigilance Reporting Support Retainer

Book an EU MDR vigilance reporting support retainer online. Compare vetted consultants who assist with serious incident triage, FSCA coordination, and competent authority reporting. Instant pricing.

✓ 3 active providers available right now · EUR 2,024 – 2,508

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Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 2,200	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 2,508	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 2,024	24h	3–7 days	Within 2 business days

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Scope

Vigilance + FSCA triage

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Regulation

EU MDR Art. 87–90

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Pricing

Monthly / annual retainer

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SLA

Response within SLA of provider

How it works

1

Describe your device and complaint volume

Tell us your device class, approximate annual complaint volume, and whether you need reactive support only or proactive vigilance process setup.
2

Compare vigilance support retainers

View monthly fees and SLAs from consultants who provide standing vigilance reporting support and FSCA coordination.
3

Enroll and get your vigilance workflow in place

Your consultant sets up or reviews your reporting triage criteria, templates, and competent authority communication process.

What is EU MDR vigilance reporting?

EU MDR 2017/745 Articles 87–90 establish a vigilance system requiring medical device manufacturers to report serious incidents and Field Safety Corrective Actions (FSCAs) to competent authorities in the EU member states where the affected devices were distributed. A "serious incident" is any malfunction or deterioration in the characteristics of a device, inadequacy in labelling, or inadequacy in the IFU that has led to, or could have led to, the death or serious deterioration in health of a patient, user, or other person. Unlike the US MDR system (which routes all reports to FDA), EU vigilance requires reporting to each national competent authority in affected member states — this means up to 27 separate competent authorities may need to be notified for a single incident affecting pan-EU distributed devices.

Vigilance reporting timelines under EU MDR

EU MDR imposes strict reporting timelines: (1) serious incidents that constitute a serious public health threat must be reported immediately, and no later than 2 calendar days after the manufacturer becomes aware; (2) incidents that led to or might lead to death or an unanticipated serious deterioration in health must be reported within 10 calendar days; (3) all other reportable serious incidents must be reported within 15 calendar days. FSCAs must be reported to authorities before they are implemented, or simultaneously in urgent cases. These timelines run from the day the manufacturer "becomes aware" — which means your complaint handling intake process must be designed to flag potential vigilance events immediately to the team responsible for triage.

What is a Field Safety Corrective Action (FSCA)?

An FSCA is any action taken by a manufacturer to reduce a risk of death or serious injury associated with a medical device that is already on the market. FSCAs include: device withdrawals; device modifications (hardware, software, IFU); label corrections; and restrictions on use. When an FSCA is taken, a Field Safety Notice (FSN) must be distributed to all customers and users who received the affected devices. The FSN must be communicated in the official language(s) of the affected EU member states. Both the FSCA and FSN must also be reported to competent authorities via EUDAMED (when the vigilance module is fully mandatory) or through national reporting channels. The EC REP typically coordinates competent authority notifications for non-EU manufacturers.

Why a standing vigilance support retainer makes sense

Vigilance incidents are inherently unpredictable and time-critical. Having a regulatory consultant on retainer — rather than attempting to find one during an active incident — means you have an expert immediately available when a potential vigilance event is flagged. A vigilance retainer typically covers: standing triage support (reviewing incoming complaints for vigilance reportability under a defined SLA); template maintenance (keeping your trend report templates and FSN templates current with regulatory guidance); competent authority relationship management (ensuring your EC REP is coordinating correctly with each relevant national authority); and proactive monitoring of regulatory guidance updates that may affect your reporting thresholds.

Frequently asked questions

What are the EU MDR vigilance reporting timelines?: EU MDR Articles 87–90 require manufacturers to report serious incidents to competent authorities within: 15 calendar days (serious public health threat), 10 days (death or serious deterioration), and 30 days (other reportable incidents). FSCAs must be reported immediately.
What is the difference between vigilance reporting and FSCA?: Vigilance reporting covers the notification of serious incidents and trends to competent authorities. A Field Safety Corrective Action (FSCA) is a remedial action taken to reduce risk — it must be communicated via a Field Safety Notice (FSN) and also notified to authorities.
Is vigilance reporting handled by the manufacturer or the EC REP?: The manufacturer is primarily responsible for vigilance reporting. The EC REP may assist in communication with EU competent authorities, but they cannot substitute for the manufacturer's primary responsibility.

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