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Annex XVI products

Products without an intended medical purpose covered by MDR Annex XVI.

Official catalogue · non-binding

Annex XVI products 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 2023-5Guidance on qualification and classification of 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 2023-5PDF · 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.

Q&AQ&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRSeptember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Annex XVI products
Published
September 2023
Topics

Source document

  • Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRPDF · 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.