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Article 36

Reproduced from official EUR-Lex 1/1/2026.

Article 36

Requirements relating to notified bodies

1.

Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII.

In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself.

The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.

2.

Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.

3.

In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Official catalogue · non-binding

Related guidance (9)

Current English catalogue entries that refer to Article 36. Guidance is non-binding and kept separate from the regulation text.

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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

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  • 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.

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MDCG 2024-6Preliminary re-assessment review (PRAR) form template (MDR)May 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
May 2024
Topics

Source document

  • MDCG 2024-6DOCX · 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 2024-7 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexPreliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents)January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
January 2025
Topics

Source documents

  • MDCG 2024-7 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 2021-15/MDCG 2024-7 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.

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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.

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MDCG 2022-13 rev.1Designation, re-assessment and notification of conformity assessment bodies and notified bodiesJune 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
June 2024
Topics

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  • MDCG 2022-13 rev.1PDF · 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 2021-15 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)Annex to Application Form & PAR Template MDR (List of documents)January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
January 2025
Topics

Source documents

  • MDCG 2021-15 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 2021-15/MDCG 2024-7 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.

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MDCG 2022-11 - rev.1MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirementsNovember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
November 2023
Topics

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  • MDCG 2022-11 - rev.1PDF · 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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Q&A rev.2Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsJuly 2024
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
July 2024
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.

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Show all 9 guidance documentsShow only the first 8
MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
August 2022
Topics

Source document

  • MDCG 2022-14PDF · 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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