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Summary of safety and clinical/performance information

SSCP or SSP preparation, publication, and management.

Official catalogue · non-binding

Summary of safety and clinical/performance information guidance (3)

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

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MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
March 2022
Topics

Source document

  • MDCG 2019-9 - rev.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 2026-4MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory useJune 2026
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
June 2026
Topics

Source document

  • MDCG 2026-4PDF · 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 2022-9 rev.1Summary of safety and performance templateApril 2024
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
April 2024
Topics

Source document

  • MDCG 2022-9 rev.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.