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Interruption or discontinuation of supply

Notification obligations when supply of devices is interrupted or discontinued.

Official catalogue · non-binding

Interruption or discontinuation of supply guidance (5)

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

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Gradual roll out of EUDAMEDQ&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1November 2024
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
November 2024
Topics

Source document

  • Gradual roll out of EUDAMEDPDF · 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&A rev.2Q&A Obligation to inform in case of interruption or discontinuation of supplyApril 2026
Non-binding guidanceOpen guidance page
Catalogue section
Article 10a – interruption or discontinuation of supply
Published
April 2026
Topics

Source document

  • Q&A rev.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 2024-16Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devicesDecember 2024
Non-binding guidanceOpen guidance page
Catalogue section
Article 10a – interruption or discontinuation of supply
Published
December 2024
Topics

Source document

  • MDCG 2024-16PDF · 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.

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MDCG 2024-16 AnnexDevice Identification tableDecember 2024
Non-binding guidanceOpen guidance page
Catalogue section
Article 10a – interruption or discontinuation of supply
Published
December 2024
Topics

Source document

  • MDCG 2024-16 AnnexPDF · 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.

Guidance documentArticle 10a Decision treeApril 2026
Non-binding guidanceOpen guidance page
Catalogue section
Article 10a – interruption or discontinuation of supply
Published
April 2026
Topics

Source document

  • Article 10a Decision treePDF · 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.