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Article 35

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

Article 35

Authorities responsible for notified bodies

1.

Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.

2.

The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies.

3.

The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment.

4.

The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis.

5.

The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities.

6.

The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks.

Where the authority responsible for notified bodies is a different authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters.

7.

Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks.

8.

The authority responsible for notified bodies shall participate in the peer-review activities provided for in Article 48.

Official catalogue · non-binding

Related guidance (5)

Current English catalogue entries that refer to Article 35. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
June 2024
Topics

Source document

  • MDCG 2024-10PDF · 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 2024-3 MDCG 2024-3 Appendix AGuidance on content of the Clinical Investigation Plan for clinical investigations of medical devicesClinical Investigation Plan Synopsis TemplateMarch 2024March 2024
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
March 2024March 2024
Topics

Source documents

  • MDCG 2024-3PDF · 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 2024-3 Appendix ADOCX · 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 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
December 2025
Topics

Source document

  • MDCG 2025-9PDF · 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 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

Source document

  • 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.

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 2024-12 MDCG 2024-12 Annex I Form MDCG 2024-12 Annex II FormCorrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teamsAnnex I: Template CAPA plan and assessment thereonAnnex II: Template JAT review of the CAPA and the DA's opinionOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
October 2024
Topics

Source documents

  • MDCG 2024-12PDF · 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 2024-12 Annex I FormDOCX · 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 2024-12 Annex II FormDOCX · 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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