Module 19 2021

02/06/2021

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IVDR

I INTRODUCTORY PROVISIONS II MAKING AVAILABLE ON THE MARKET … III IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION … IV NOTIFIED BODIES V CLASSIFICATION AND CONFORMITY ASSESSMENT VI CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE VIII COOPERATION BETWEENMEMBER STATES… IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES X FINAL PROVISIONS

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