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Article 53

Reproduced from official EUR-Lex 10/1/2025.

Article 53

Voluntary change of notified body

1.

In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:

  1. (a)

    the date on which the certificates issued by the outgoing notified body become invalid;

  2. (b)

    the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;

  3. (c)

    the transfer of documents, including confidentiality aspects and property rights;

  4. (d)

    the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;

  5. (e)

    the last serial number or lot number for which the outgoing notified body is responsible.

2.

The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.

Official catalogue · non-binding

Related guidance (6)

Current English catalogue entries that refer to Article 53. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2024-8 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexPreliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents)January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
January 2025
Topics

Source documents

  • MDCG 2024-8 rev.1DOCX · 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.

  • MDCG 2021-16/MDCG 2024-8 AnnexDOCX · 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 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
May 2024
Topics

Source document

  • MDCG 2024-9DOCX · 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 2019-6 rev.5Questions and answers: Requirements relating to notified bodiesFebruary 2025
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
February 2025
Topics

Source document

  • MDCG 2019-6 rev.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.

MDCG 2021-16 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)Annex to Application Form & PAR Template IVDR (List of documents)January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
January 2025
Topics

Source documents

  • MDCG 2021-16 rev.1DOCX · 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.

  • MDCG 2021-16/MDCG 2024-8 AnnexDOCX · 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 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
November 2018
Topics

Source document

  • MDCG 2018-8PDF · 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 practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860July 2024
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
July 2024
Topics

Source document

  • Q&APDF · 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.

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