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EUDAMED vigilance module

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Regulatory basis - MDR Art. 92 and Art. 100–105 / IVDR Art. 87 and Art. 97–102. EUDAMED is the central EU information system for medical devices, including the vigilance module for reporting serious incidents and FSCAs.

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Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

Role of EUDAMED in vigilance​

EUDAMED's vigilance module centralises the exchange of safety information between:

  • Manufacturers (and EU REPs) — who submit reports
  • National Competent Authorities — who receive, review, and act on reports
  • The European Commission and MDCG — who monitor trends across the EU

Before EUDAMED, vigilance reports were submitted directly to individual NCAs using national forms and portals. EUDAMED standardises the process and enables real-time data sharing across member states.

What the vigilance module handles​

Report typeDescription
Serious incident reportsInitial and final reports for events meeting the Art. 87 / Art. 82 definition
FSCA notificationsNotification of field safety corrective actions before or concurrent with implementation
Field safety notices (FSNs)The communication sent to users/customers about FSCAs — uploaded and linked to FSCA notification
Trend reportsArt. 88 / Art. 83 statistical trend reports
Manufacturer periodic summariesWhere permitted by the NCA, periodic summary reports for similar incidents
NCA responses and queriesBidirectional communication between manufacturer and NCA

Access and registration​

To use EUDAMED vigilance module, manufacturers must:

  1. Register as an economic operator in EUDAMED (obtain an SRN)
  2. Complete the identity verification process for EUDAMED user accounts
  3. Assign roles within the organisation — who can submit vigilance reports, access NCA responses, etc.

Non-EU manufacturers must ensure their EU authorised representative is registered and has EUDAMED access, as the EU REP may submit reports on the manufacturer's behalf.

Submitting a report — key steps​

  1. Log in to EUDAMED with verified credentials
  2. Create a new vigilance report — select report type (serious incident, FSCA notification)
  3. Enter device details — link to the registered UDI/device in EUDAMED
  4. Complete structured fields — incident description, outcome, patient impact, device analysis status
  5. Select target NCA(s) — one or multiple member states
  6. Submit — report is transmitted to the selected NCA(s)
  7. Track status — monitor NCA acknowledgements and queries within EUDAMED

Trend reporting — MDR Art. 88 / IVDR Art. 83​

Trend reporting is a proactive vigilance obligation distinct from individual serious incident reports. Manufacturers must report to the relevant NCA if they notice:

A statistically significant increase in the frequency or severity of non-serious incidents, or expected side-effects, that could have a significant impact on the benefit-risk analysis for the device

What triggers a trend report?​

  • An unexpected cluster of the same non-serious malfunction across multiple units or sites
  • An increase in complaint rates for a specific failure mode beyond pre-defined thresholds in the PMS plan
  • A pattern of expected side effects occurring more frequently than anticipated

Key point — non-serious incidents​

Trend reports cover events that are individually non-reportable as serious incidents but collectively suggest a systemic problem. Each individual event did not meet the Art. 87 threshold — but the aggregate trend does.

How to define thresholds​

Manufacturers should define baseline rates and alert thresholds for common complaint types in their PMS plan. When the PMS data breaches these thresholds, this triggers the trend report assessment.

NCA responses and follow-up​

After submitting a report, manufacturers should expect:

  • Acknowledgement of receipt within EUDAMED
  • Potential requests for additional information — NCA may query specific details, request device return for analysis, or ask for a timeline to final report
  • Possible NCA-initiated actions — an NCA may initiate field safety actions independently if it believes the manufacturer's response is insufficient

Manufacturers must respond to NCA queries promptly. Response obligations are part of the broader obligation to cooperate with competent authorities (MDR Art. 10(12)).

Official references​

ReferenceDescription
MDR Art. 88Trend reporting
IVDR Art. 83IVDR trend reporting
MDR Art. 92European database — vigilance
MDR Art. 100–105EUDAMED general provisions
EUDAMED user guidesec.europa.eu/tools/eudamed
MDCG 2023-3Serious incident and vigilance reporting guidance