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 !
View Waters IVDR Position Statement
Webinar - Update on the IVDR and implications for in house IVD’s Register now >>> A webinar looking at the impact of In Vitro Diagnostic Regulation (IVDR) for Clinical lab and MS users. During this session, we'll discuss the last updates on IVDR regulation and discuss the implications for in house IVD's
Webinar presented by Robyn Meurant - Principal Consultant at ACT-IVD
On-demand Webinar - IVDR implementation for clinical laboratories - Current state of play - July, 8th 2021 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
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