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Article 36

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

Article 36

Nomination of experts for joint assessment of applications for notification

1.

The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the activities referred to in Articles 35 and 44.

2.

The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referred to in Article 52.

Official catalogue · non-binding

Related guidance (6)

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

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.

MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
July 2022
Topics

Source document

  • MDCG 2022-12PDF · 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.

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 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 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

Source document

  • 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.

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 2022-14Transition 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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