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IVD classification

Classification and qualification of in vitro diagnostic devices.

Official catalogue · non-binding

IVD classification guidance (2)

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

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MDCG 2024-11Guidance on qualification of in vitro diagnostic medical devicesOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
October 2024
Topics

Source document

  • MDCG 2024-11PDF · 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 2020-16 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.