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Vigilance

Incident reporting, trend reporting, and vigilance concepts.

Official catalogue · non-binding

Vigilance guidance (2)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2024-1Device Specific Vigilance Guidance (DSVG) TemplateJanuary 2024
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
January 2024
Topics

Source document

  • MDCG 2024-1PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2023-3 rev.2Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
January 2025
Topics

Source document

  • MDCG 2023-3 rev.2PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.