Materiovigilance and the MDR vigilance system: complete 2026 guide

Vigilance is one of the most operational post-market obligations of the MDR. It imposes strict deadlines, European forms and coordination between the manufacturer, national competent authorities and the European Commission. This guide details what you must do, when, and how.

From national materiovigilance to the MDR vigilance system

Before the MDR, medical device vigilance relied on the Directives and on national systems. Since 26 May 2021, the MDR vigilance system (Articles 87 to 92) applies to all devices placed on the EU market, including those still covered by a certificate issued under the Directive: Article 120(3) subjects these "legacy" devices to the MDR requirements on post-market surveillance and vigilance.

National materiovigilance has not disappeared. In France, the Public Health Code (Article L.5212-2 and Articles R.5212-1 et seq.) still organises reporting by health professionals and institutions, with a local materiovigilance correspondent in each institution.

Which events must be reported?

MDR Article 87 requires the manufacturer to report:

• any serious incident involving a device made available on the EU market, except expected side-effects that are clearly documented in the product information, quantified in the technical documentation and subject to trend reporting;
• any field safety corrective action (FSCA), including one undertaken in a third country for a device also made available in the EU.

Serious incident

Under MDR Article 2(65), an incident is serious if it directly or indirectly led, might have led or might lead to:

• the death of a patient, user or other person;
• the temporary or permanent serious deterioration of a patient's, user's or other person's state of health;
• a serious public health threat.

💡 When in doubt about seriousness, report. A report later judged non-serious costs little; an unreported serious incident exposes the manufacturer and its PRRC.

What generally does not need reporting

• Expected side-effects, under the conditions above: they fall under trend reporting
• Events due solely to the natural progression of the patient's condition, unrelated to the device
• Deliberate, not reasonably foreseeable misuse, which must still be analysed

MDCG 2023-3 (questions and answers on vigilance terms and concepts) details these criteria and their borderline cases.

Field safety corrective action (FSCA)

An FSCA is a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident related to a device made available on the market. It may take the form of:

• a recall or withdrawal;
• a modification or exchange of the device;
• an update of the instructions for use;
• destruction of the device.

It comes with a field safety notice (FSN) addressed to users.

Reporting deadlines

Type of event	Maximum deadline
Serious public health threat	2 days after awareness
Death or unanticipated serious deterioration in health	10 days after awareness
Other serious incident	15 days after awareness
FSCA	Before it is undertaken, except in urgent cases
Trend report	As soon as a statistically significant increase is identified

⚠️ Deadlines run from the moment the manufacturer becomes aware of the incident, and the causal relationship may only be suspected. Your procedure must define how and by whom awareness is formalised. Where needed, an incomplete initial report is sent within the deadline and completed later.

How to report

The current channel

The EUDAMED vigilance module is not mandatory yet. The manufacturer therefore reports the serious incident to the competent authority of the Member State where it occurred, using the European MIR form (Manufacturer Incident Report). FSCAs are reported with the dedicated European form, and the field safety notice is sent to the authority before distribution.

Once the vigilance module is declared fully functional, these reports will go through EUDAMED.

The authorised representative's role

A manufacturer established outside the EU may rely on its authorised representative for exchanges with authorities, but reporting responsibility remains with the manufacturer. The mandate should specify roles and internal deadlines.

The PSUR (periodic safety update report)

The PSUR, provided for in MDR Article 86, summarises the results and conclusions of the analysis of post-market surveillance data, together with the rationale for any preventive and corrective actions taken.

Frequency:

• Classes IIb and III: at least annually
• Class IIa: when necessary and at least every two years
• Class I: no PSUR, but a post-market surveillance report (Article 85), updated when necessary

Typical content:

1. Sales volume and estimated user population
2. Summary of complaints, serious incidents and FSCAs
3. Post-market surveillance results
4. Main PMCF findings
5. Conclusions on the benefit-risk ratio

For class III and implantable devices, the PSUR is submitted to the notified body, which evaluates it; for other classes, it is kept available to the notified body and competent authorities.

The trend report

Less known than the PSUR, the trend report (MDR Article 88) is just as important. The manufacturer submits it when it identifies a statistically significant increase in the frequency or severity of non-serious incidents or expected side-effects that could significantly affect the benefit-risk analysis.

In practice, this requires:

1. defining, in the post-market surveillance plan, the indicators and thresholds that trigger analysis;
2. regularly analysing complaints and field feedback;
3. documenting the statistical method used.

Integrating vigilance into the QMS

Vigilance connects with several ISO 13485:2016 requirements:

• § 8.2.1 — Feedback: collecting information from production and post-production
• § 8.2.2 — Complaint handling: the first source of potential incidents
• § 8.2.3 — Reporting to regulatory authorities: the reporting procedure itself
• § 8.3 — Control of nonconforming product, including after delivery
• § 8.5.2 — Corrective action: every FSCA belongs to the CAPA process

Your vigilance procedure must define:

• the criteria for qualifying a serious incident;
• owners and internal deadlines, shorter than the regulatory ones to leave time for checks;
• the validation circuit for reports, under the PRRC's supervision;
• archiving of reporting evidence.

What MedQara monitors in this area

Vigilance rules evolve regularly:

• MDCG documents on interpreting criteria and forms;
• roll-out of the EUDAMED vigilance module;
• competent authority communications on materiovigilance;
• safety notices and recalls published by authorities, useful for comparative risk analysis.

MedQara analyses each publication and tells you how it affects your scope, based on your device profile.

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