In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is in application - Do you need help?

At Waters, we are fully committed to and are actively working towards ensuring IVD-R compliance. Currently, we have a 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:

• MassTrak ACQUITY UPLC I-Class PLUS Xevo TQD IVD System
• MassTrak ACQUITY UPLC I-Class PLUS Xevo TQ-S micro IVD System
• MassTrak ACQUITY UPLC I-Class PLUS Xevo TQ-XS IVD System
• RenataDX Screening System

To answer your questions, take a look at our IVDR FAQ !

Waters IVDR latest news

On-demand Webinar - Update on the IVDR and implications for in house IVD’s
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 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

Waters latest IVDR blog post - The IVDR Cake. We’ve got a slice!
Read now >>>

Are you IVDR compliant? Clinical Diagnostics is continuously changing, and it is imperative to adjust to new regulations. Explore our MassTrak IVD Portfolio that allows you to customize your LC-MS solution while remaining compliant with the latest In Vitro Diagnostic Medical Device Regulations.

Would you like to know more on IVDR and Waters IVD solutions? Get in touch with one of our clinical experts