Skip to main content

2 docs tagged with "annexes"

View all tags

IVDR Annexes — all 16

Annexes I–XVI of Regulation (EU) 2017/746 (IVDR). The IVDR annexes mirror the MDR structure with adaptations for the in vitro diagnostic context.

MDR Annexes — all 17

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.