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 mirror the MDR structure with significant adaptations for the in vitro diagnostic context, including classification rules, conformity assessment procedures, and performance evaluation requirements specific to IVDs.

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.