Free medical device safety education

Learn vigilance. Think in cases.

A practical learning platform for medical device and IVD vigilance — from awareness and incident intake to reportability assessment, investigation, FSCA/FSN, trend reporting, post-market surveillance and safety-system oversight.

Open Case Triage ToolExplore the learning map
12learning stages
9role pathways
3assessment levels
01 / Orientation

What materiovigilance actually does.

Medical device vigilance is the safety-feedback system that turns real-world device incidents, near misses, failures and emerging patterns into investigation, regulatory reporting, corrective action and safer products. It sits inside the wider post-market surveillance lifecycle.

Not every complaint is reportable. Every complaint may need assessment.

A good vigilance system does not begin with a deadline. It begins with accurate intake, clinical and technical context, product identification, traceability and a disciplined assessment of what happened, what could happen, and whether a causal relationship with the device is reasonably possible.

Manufacturers remain central to formal MDR/IVDR vigilance reporting, while authorised representatives, importers, distributors, healthcare institutions, professionals and patients can all create information that must reach the right safety process quickly.

IncidentA malfunction, deterioration, use error due to ergonomic features, inadequacy of supplied information or undesirable side-effect, within the regulatory concept.
Serious incidentAn incident that directly or indirectly led, might have led or might lead to death, serious deterioration of health, or a serious public health threat.
FSCAField safety corrective action taken for technical or medical reasons to prevent or reduce the risk of a serious incident.
FSNField safety notice: the manufacturer’s communication to users/customers concerning an FSCA.
Trend reportingDetection and reporting of statistically significant increases in frequency or severity of certain non-serious incidents or expected undesirable side-effects when required.
PMSA proactive, systematic post-market process that continuously feeds benefit-risk, clinical/performance evaluation, risk management and corrective action.
02 / Learning map

From awareness to safety-system mastery.

Progress in sequence if you are new, or jump directly to the stage that matches your responsibility. Each stage combines compact theory, practical judgement, regulatory anchors and a route to official sources.

03 / Interactive tool

Case Triage Compass.

Use a hypothetical case to practise the sequence of questions that should be considered before a vigilance decision. The tool teaches the logic; it does not replace your manufacturer procedure, competent authority guidance or expert regulatory assessment.

Educational decision support

Describe the case at a high level.

Do not enter patient names or personal data. Select the closest scenario. The output is deliberately conservative and points you to the next questions and official sources.

04 / Role pathways

Learn what your role actually needs.

A hospital user, distributor, vigilance specialist and PRRC do not need the same depth. Select a role to see a practical sequence from baseline awareness to role-specific competence.

05 / Official source map

Go back to the source.

Guidance changes. Your organisation should always verify the current effective regulation, competent authority instructions, MDCG guidance and applicable procedures before making a real vigilance decision.

06 / Current landscape

EUDAMED in 2026.

As of 28 May 2026, Actor registration, UDI/Device registration, Notified Bodies & Certificates and Market Surveillance are mandatory modules. The Vigilance/Post-Market Surveillance module remains under development, so users must follow the Commission’s current rollout information and applicable national/transition processes.

MANDATORYsince 28 May 2026

Actor registration

Economic operator identification and Single Registration Number workflows are now part of mandatory EUDAMED use where applicable.

MANDATORYsince 28 May 2026

UDI / Devices

Device registration and identification strengthen traceability across the lifecycle and support safer post-market processes.

IN DEVELOPMENTverify current status

Vigilance / PMS

Do not assume the future EUDAMED vigilance workflow is already mandatory. Check the European Commission’s current implementation status before operational use.

07 / Job aids

Practical aids for the workday.

Use these as learning prompts when preparing local procedures, onboarding colleagues or reviewing a case. They are not controlled company forms.

Incident intake checklist

Device identifiers, reporter, event chronology, patient/user outcome, availability of device/evidence, photos/logs, concomitant factors and immediate containment.

Practise in Case Compass

Reportability question set

Was there an incident? Is serious harm possible? Is causal relationship reasonably possible? Are exclusion criteria truly supported? Is there uncertainty that should trigger conservative reporting?

Open MDCG 2023-3 Rev.2

Evidence preservation prompt

Quarantine or secure the device where feasible, preserve accessories, packaging, logs and images, document chain of custody and avoid destructive analysis before responsibilities are agreed.

Review investigation stage

FSCA / FSN review lens

Define affected scope, risk, corrective action, distribution population, user instructions, effectiveness checks and communication consistency before deployment.

EU guidance & PMSV forms

Greek White Card route

Healthcare professionals and patients/consumers in Greece can report serious medical-device incidents through the EOF White Card route and should follow the current EOF instructions.

EOF White Card

Trend review prompt

Compare current frequency/severity against expected levels and historical baseline, stratify by device/version/market and assess whether the signal changes benefit-risk or requires action.

Review PMS & trend learning
08 / Free assessment

Test your vigilance judgement.

Select a level. Questions focus on decision logic rather than memorising isolated definitions. Immediate feedback explains why the best answer is stronger.

Knowledge Check

Choose a level and start. Each run contains 6 questions.

09 / Quick reference

Vigilance glossary.

Short definitions for recurring terms. Use the MDR/IVDR and current MDCG guidance for precise legal interpretation.

ASCreated byA. SifniotisSenior L&D Expert