Question - IVDR Requirements & Mapping

Forum - Software
#1

Does anyone know of a any meaningful control requirements from the In Vitro Diagnostic Regulation (IVDR)? I have the XLSX and their PDF, but synthesizing the verbiage to actual control requirements seems to be very tedious. If this exists already or if mapping exists, I would greatly appreciate the assist.

Thanks!
Kyle

#2

Weighing in at 157 pages and 85,000 words, the new European IVD Regulation requires serious concentration for regulatory professionals

our beloved european union never makes anything simple :slight_smile: