Unofficial consolidated textConsolidated 2026-01-01English

Article 113

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

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

SCOPE AND DEFINITIONS

MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT

IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

NOTIFIED BODIES

CLASSIFICATION AND CONFORMITY ASSESSMENT

CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS

CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

FINAL PROVISIONS

Comparing

Article 113