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Provision history · Medical Devices Regulation

Art. 113 · Penalties

Medical Devices Regulation · 32017R0745 · every version of this act · on EUR-Lex

1 change recorded across 1 version, newest first.

Twin in IVDR: Art. 106, textually similar (0.946), paired on this act's text of 19 July 2026 and the IVDR text of 10 January 2025. See where the two texts differ.

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Version in force Deferred +4 −4

Amended by Regulation (EU) 2020/561 32020R0561 on EUR-Lex

Applies from: 2021-02-25

dates added to the text: 2021-02-25 · dates removed: 2020-02-25

Explanation, written by a model and checked against the cited text

The date by which Member States must notify the Commission of the penalty rules and measures changed from 25 February 2020 to 25 February 2021.

Cited: Art. 113, v1 · Art. 113, v2

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version, detected 12 August 2026 02017R0745-20170505 → this version, in force 24 April 2020 02017R0745-20200424

Article 113 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 2020 2021 and shall notify it, without delay, of any subsequent amendment affecting them.