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IVDR Support

IVDR, IVDR support, IVDR changes

The value of IVDR

European labs and clinicians are facing significant changes to diagnostic testing. Announced in May of 2017, IVDR (in vitro diagnostic medical device regulation) is the new regulation for in vitro diagnostic medical devices in Europe. It replaces IVDD (in vitro diagnostic directive). 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.

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The value of IVDR

Updated timeline for IVDR transition

MedTech Europe welcomed the adaption of the European Commission’s amendment to the In Vitro Diagnostic medical devices Regulation (IVDR) by the European Parliament and the EU Council, that has been published in the Official Journal of the EU. Since this publication date, the amendment is fully applied in all Member States and has the effect of:

  • Maintaining the date of application of the IVD regulation of May 26, 2022;
  • Extending the IVDR transitional provisions by 3–6 years depending on the IVDR risk class 
  • No change for CE-marked devices that do not require notified body involvement under the IVD regulation (class A non-sterile, like e.g. instruments and sample preparation devices), or for devices that are ‘new', i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD regulation therefore applies from May 26, 2022 as planned.

QIAGEN welcomes the progressive roll-out of the regulation based on the IVDR risk class. This phased approach ensures the supply of key diagnostic tests while the healthcare community continues to deal with the COVID-19 pandemic.
 
Read more about the amended provision here: MedTech Europe.

Read the Official Journal of the European Union amending Regulation (EU) 2022/112.

Next steps

The amending regulation did not change any requirements of the original In Vitro Diagnostic (IVD) Regulation, which entered into force in May 2017 and became applicable on May 26, 2022. But the regulation can now be progressively rolled out with additional transitional periods depending on IVDR risk class. QIAGEN will continue to ensure we meet the IVDR needs of our customers with the same urgency and effort as before the change. Your lab can confidently approach the transition to IVDR with QIAGEN.

Next steps IVDR
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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.

We are committed to providing labs and healthcare professionals with the tests and products you need. Allowing patients to receive the answers they need.

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.