Unofficial consolidated textConsolidated 2025-01-10English

Article 80

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

Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the notified body and the competent authority upon request.

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 80