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Article 80

Reproduced from official EUR-Lex 10/1/2025.

Article 80

Post-market surveillance report

Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the notified body and the competent authority upon request.

Official catalogue · non-binding

Related guidance (4)

Current English catalogue entries that refer to Article 80. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2020-16 rev.4Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746March 2025
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
March 2025
Topics

Source document

  • MDCG 2020-16 rev.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 2022-8Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/ECMay 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
May 2022
Topics

Source document

  • MDCG 2022-8PDF · 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 2022-2Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)January 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
January 2022
Topics

Source document

  • MDCG 2022-2PDF · 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 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
December 2025
Topics

Source document

  • MDCG 2025–10PDF · 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.

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