At Waters, we are fully committed to and are actively working towards ensuring IVD-R compliance before the May 26, 2022 date of application. Currently, we have a major project team, including multiple sub teams, working to meet IVD-R requirements for labeling, product classification, clinical evidence, core quality management system updates, etc.
Not only is this critical for our business and future but also to ensure our customers and business partners are able to meet their long-term strategies.
The following Waters IVD systems are made IVD-R compliant for May 26, 2022:
To answer your questions, take a look at our IVDR FAQ !
Webinar - IVDR implementation for clinical laboratories - Current state of play - July, 8th - 11:00am CET Now available on-demand A webinar looking at the impact of In Vitro Diagnostic Regulation (IVDR) for Clinical lab and MS users. During this session, we'll outline some post-IVDR strategies for Lab Developed Tests (LDTs) and address some key areas of concern for clinical diagnostic manufacturers.
Webinar presented by Marta Carnielli - Pharm D, Technical Officer IVD - TÜV SÜD