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Performance evaluation

Performance evaluation of in vitro diagnostic devices.

Official catalogue · non-binding

Performance evaluation guidance (2)

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

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MDCG 2021-21 rev.1Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devicesFebruary 2022
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
February 2022
Topics

Source document

  • MDCG 2021-21 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 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
March 2020
Topics

Source document

  • MDCG 2020-1PDF · 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.