2 docs tagged with "annexes"

Annexes I–XVI of Regulation (EU) 2017/746 (IVDR). The IVDR contains 16 Annexes (compared to MDR's 17) that largely mirror the MDR structure with significant adaptations for the in vitro diagnostic context. Key differences include IVD-specific classification rules, conformity assessment procedures emphasizing analytical and clinical performance rather than clinical investigations, and performance evaluation requirements that focus on analytical validity, clinical validity, and clinical utility.

Annexes I–XVII of Regulation (EU) 2017/745 (MDR). The annexes contain the detailed technical, procedural, and administrative requirements that implement the principles set out in the articles.