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Unofficial consolidated textConsolidated 2026-01-01English

Article 111

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

Article 111

Levying of fees

1.

This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles.

2.

Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly available on request.

Official catalogue · non-binding

Related guidance (2)

Current English catalogue entries that refer to Article 111. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2025-6PDF · 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.

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