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Clinical evidence

Sufficiency and general principles of clinical evidence.

Official catalogue · non-binding

Clinical evidence guidance (2)

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

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MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesBackground note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluationApril 2020
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
April 2020
Topics

Source documents

  • MDCG 2020-6PDF · 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.

  • Background notePDF · 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.