Unofficial consolidated textConsolidated 2025-01-10English

Article 75

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

Review of the coordinated assessment procedure

By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on the experience gained from the application of Article 74 and, if necessary, propose a review of Article 74(14) and point (g) of Article 113(3).

INTRODUCTORY PROVISIONS

MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, 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 EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS

CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

FINAL PROVISIONS

Comparing

Article 75