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Unofficial consolidated textConsolidated 2025-01-10English

Article 106

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

Article 106

Penalties

The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them.

Official catalogue · non-binding

Related guidance (1)

Current English catalogue entries that refer to Article 106. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2021-4 rev.1Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746September 2024
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
September 2024
Topics

Source document

  • MDCG 2021-4 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.

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