European Commission
EU Adopts Amendment for IVD Regulation Transition
The IVDR will still come into effect on May 26, 2022, but manufacturers of tests cleared before that date will have more time to achieve compliance under the new regulation.
European Commission Adopts Interim Measure to Hold Grail Separate From Illumina
The measures are legally binding for both Illumina and Grail, and compliance with them will be monitored by a trustee to be approved by the commission.
Industry observers have welcomed the proposal but cautioned that many challenges remain, regardless of its application date.
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EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access
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The EC has stuck with its timeline to implement the new regulations in eight months, raising concerns for cancer patients' ability to receive biomarker testing and treatments.
European laboratories that modify existing assays or make their own tests to better care for patients are staring at a substantial increase in oversight.