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Medical Device Regulation (MDR)
Article 113

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 ►M1 25 February 2021 and shall notify it, without delay, of any subsequent amendment affecting them.