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Notified-body audits

Audit methods and extraordinary audit arrangements for notified bodies.

Official catalogue · non-binding

Notified-body audits guidance (4)

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

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MDCG 2022-17MDCG position paper on "hybrid audits"December 2022
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
December 2022
Topics

Source document

  • MDCG 2022-17PDF · 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.

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MDCG 2020-17Questions and Answers related to MDCG 2020-4:“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”December 2020
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
December 2020
Topics

Source document

  • MDCG 2020-17PDF · 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 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
August 2020
Topics

Source document

  • MDCG 2020-14PDF · 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 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
April 2020
Topics

Source document

  • MDCG 2020-4PDF · 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.