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Getting ready for the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

 
IVDR timeline
 

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:​

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

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

 
IVDR implementation deadline
  


On-demand Waters IVDR events

 

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

 
Watch on-demand
 


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

 


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