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SARS-CoV-2 diagnostic tests

Qualification, performance, and market guidance for SARS-CoV-2 diagnostic tests.

Official catalogue · non-binding

SARS-CoV-2 diagnostic tests guidance (4)

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 2022-1Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devicesJanuary 2022
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
January 2022
Topics

Source document

  • MDCG 2022-1PDF · 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 2021-7Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devicesMay 2021
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
May 2021
Topics

Source document

  • MDCG 2021-7PDF · 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.

Guidance documentCOVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (available in all EU languages and Arabic , Chinese , Japanese , Russian )February 2021
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
February 2021
Topics

Source documents

  • COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19PDF · 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.

  • ArabicPDF · 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.

  • ChinesePDF · 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.

  • JapanesePDF · 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.

  • RussianPDF · 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.