Materiovigilance and the MDR vigilance system: complete 2026 guide

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

From the French materiovigilance system to the MDR vigilance system

Before the MDR, materiovigilance in France was managed exclusively via the ANSM portal (reporting by manufacturers and healthcare professionals). The MDR created a harmonised European system, but the two coexist:

• French materiovigilance (Article L.5212-2 of the Public Health Code) still applies to devices still under Directive 93/42/EEC ("legacy" devices in the transition period)
• The MDR vigilance system (Articles 87 to 92 and Annex III) applies to devices certified under the MDR

In practice, most manufacturers run both systems in parallel in 2026.

Which events trigger a report?

Article 87 of the MDR sets out the reporting obligation for any serious incident or field safety corrective action (FSCA) carried out outside the European Union.

Serious incident

An incident is "serious" within the meaning of the MDR if, directly or indirectly, it led or might have led to:

• The death of a patient, user or other person
• A serious and permanent deterioration in the state of health of a patient, user or other person
• A serious public health threat

💡 Precautionary principle: when in doubt about severity, report. The cost of an unjustified report is negligible compared with the risk of not reporting an incident that turns out to be serious.

What is NOT a reportable serious incident

• Expected malfunctions documented in the IFU (Instructions for Use) — provided they do not cause serious harm and mitigation measures are in place
• Events due to obvious incorrect use that is not reasonably foreseeable
• Events linked to the patient's condition (natural progression of the disease)

Field Safety Corrective Action (FSCA)

An FSCA is any corrective action taken by the manufacturer to reduce a risk of death or serious deterioration in health associated with a device already placed on the market. It may include:

• Withdrawal from the market (recall)
• Modification of the device
• Exchange of the device
• Update of the IFU
• Urgent information to users (FSN — Field Safety Notice)

Reporting deadlines

Type of event	Deadline
Serious public health threat	2 days after becoming aware
Death or unexpected serious deterioration	10 days after becoming aware
Serious incident (other cases)	15 days after becoming aware
FSCA (other than serious threat)	15 days before the action begins
Trend report	Quarterly or on request

⚠️ Deadlines start from the moment the manufacturer becomes aware of the event — not from the date the incident occurred. Define in your vigilance procedure how and by whom "awareness" is formalised.

How to report: the official channels

For devices under the MDR

Reporting is done via EUDAMED — Vigilance Module (module 5). The form is standardised at European level (MEDDEV 2.12/1 rev 8 and the EU-MDR-SI form).

The manufacturer reports to the competent authority of the Member State where the incident occurred. In France, that is ANSM. For incidents occurring in several Member States, reporting can be made to the authority of the Member State where the manufacturer (or European authorised representative) is established.

For devices under the directive (legacy)

Reporting via the ANSM reporting portal (ansm.sante.fr → Report an incident).

The role of the European authorised representative (AR)

If you are a non-EU manufacturer, your European authorised representative can handle reporting on your behalf. But the responsibility remains that of the manufacturer. Your contractual agreements with your AR must specify roles and deadlines.

The PSUR (Periodic Safety Update Report)

The PSUR is a periodic report summarising and evaluating all the safety data available on the device since it was placed on the market.

Mandatory frequency:

• Class III and implantable IIb: every year
• Class IIa and non-implantable IIb: every 2 years
• Class I: integrated into the post-market surveillance report (PMS Report), no formal PSUR

PSUR content:

1. Production and sales data (volumes)
2. Summary of complaints
3. Summary of reported serious incidents and FSCAs
4. Post-market surveillance (PMS) results
5. PMCF (Post-Market Clinical Follow-up) results
6. Conclusion on the benefit/risk balance and the acceptability of the residual risk profile

The PSUR is sent to the notified body which examines it as part of continuous certificate surveillance.

The trend report

Less well known than the PSUR, the trend report (Article 88 MDR) is nonetheless important. The manufacturer must submit it to the competent authority when it observes a statistically significant increase in the frequency or severity of non-serious incidents, side effects, or expected incidents.

In practice, this requires:

1. Defining surveillance indicators and alert thresholds in your PMS procedure
2. Regularly analyzing complaint and field feedback data
3. Triggering the trend report if thresholds are crossed

Integrating vigilance into your QMS

Vigilance is not a silo — it integrates with several ISO 13485 processes:

• § 8.2.2 — Complaints: customer complaints are a source for identifying potential incidents
• § 8.5.1 — Corrective actions: every FSCA triggers a corrective action process
• § 8.3 — Control of nonconforming product: product nonconformities detected after commercialisation may require a vigilance assessment
• § 7.2 — Customer satisfaction: field feedback feeds PMS surveillance

Your vigilance procedure must define:

• The criteria for qualifying a serious incident
• The owners and internal deadlines (generally: internal deadline = regulatory deadline − 3 days for checks)
• The validation circuit for reports (PRRC, medical management if applicable)
• The archiving of reporting evidence

What MedQara monitors in this field

Vigilance regulation is constantly evolving:

• New MDCG decisions on the interpretation of serious incident criteria
• Updates to EUDAMED reporting forms (frequent in 2025-2026)
• Device recalls published by ANSM and the FDA (useful for comparative risk analysis)
• ANSM communications on vigilance trends by specialty

Our AI analyzes each publication and tells you its impact on your scope, according to your device profile.

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