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Equivalence

Use and demonstration of equivalence for clinical evaluation or Annex XVI products.

Official catalogue · non-binding

Equivalence guidance (3)

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

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MDCG 2023-6Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodiesDecember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Annex XVI products
Published
December 2023
Topics

Source document

  • MDCG 2023-6PDF · 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.

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 2023-7Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalenceDecember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
December 2023
Topics

Source document

  • MDCG 2023-7PDF · 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.

MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
April 2020
Topics

Source document

  • MDCG 2020-5PDF · 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.