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Corrective and preventive action (CAPA)

CAPA plans and their assessment for notified-body/designating-authority processes.

Official catalogue · non-binding

Corrective and preventive action (CAPA) guidance (1)

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

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MDCG 2024-12 MDCG 2024-12 Annex I Form MDCG 2024-12 Annex II FormCorrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teamsAnnex I: Template CAPA plan and assessment thereonAnnex II: Template JAT review of the CAPA and the DA's opinionOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
October 2024
Topics

Source documents

  • MDCG 2024-12PDF · 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.

  • MDCG 2024-12 Annex I FormDOCX · 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.

  • MDCG 2024-12 Annex II FormDOCX · 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.