IVDR Support

The value of IVDR

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 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.

Updated timeline for IVDR transition

Recently MedTech Europe welcomed the adaption of the European Commission’s proposed amendment to the In Vitro Diagnostic medical devices Regulation (IVDR) by the European Parliament and the EU Council. It follows as the last step of the publication of the amendment in the Official Journal of the EU in short times. From this date the amendment will fully apply in all Member States and will have 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 will therefore apply from May 26, 2022 as planned.

QIAGEN welcomes the progressive roll-out of the regulation based on the IVDR risk class. This phased approach will ensure 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.

Next steps

The amending regulation does not change any requirements of the original In Vitro Diagnostic (IVD) Regulation, which entered into force in May 2017 and becomes 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.

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.