Two colleagues talking in a lab

IVDR Support

The value of IVDR

In the coming months, European labs and clinicians will face significant changes to diagnostic testing. Announced in May of 2017, IVDR (in vitro diagnostic medical device regulation) will be the new regulation for in vitro diagnostic medical devices in Europe. It will replace IVDD (in vitro diagnostic directive) in May 2022. In essence, the European Union is moving from a directive-based system to an approach that now is European regulation.

Advances in testing, technology and international standards were considered in the development of the IVDR regulation, resulting in changes to provide higher quality, safety and reliability of IVD tests.  

The value of IVDR to your lab is clear. Changes brought by the new IVDR regulations will increase patient safety, allowing your lab to work with high-end reagents, further increasing the quality of the results you are delivering.

Image from Biolab in Oman
Image from CorpCom Apps Lab

Transitioning to IVDR with QIAGEN

While IVDR changes will provide increased assurance throughout diagnostic testing across European healthcare systems, there are certain to be questions along the way. Successful transition to new IVDR standards requires preparation.

At QIAGEN, we are deeply invested and committed to the transition. Since the inception of the IVDR, QIAGEN has been in the forefront of the evolution and implementation of the regulations. QIAGEN proudly serves on multiple committees and works closely with MedTech Europe in the discussions with the European Commission.

With QIAGEN, your lab can approach the transition to IVDR with confidence. We are committed to providing labs and healthcare professionals with the tests and products you need. Allowing patients to receive the answers they need.

 

IVDR implementation timeline
Learn more about our IVDR plans

At QIAGEN, over 180 products fall within the scope of IVDR implementation. We have planned for this transition and are currently working across our various areas of expertise to ensure QIAGEN is IVDR-ready when the time comes.

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