European Commission
A shortage of regulatory capacity continues to slow the implementation of the EU's In Vitro Diagnostic Regulation.
European Commission Outlines Intended Restorative Measures for Blocked Illumina-Grail Deal
In a Statement of Objections, the agency laid out the intended divestment and transitional measures for Illumina to unwind and dissolve the Grail acquisition.
EU to Disallow Illumina's Grail Purchase
Separately, the US Federal Trade Commission said it will appeal an administrative law judge's initial decision in an antitrust case that was favorable to Illumina.
Roche Gets Expanded CE Mark for Ventana PD-L1 Assay to ID NSCLC Patients for Tecentriq
The test gained European approval to identify PD-L1-expressing non-small cell lung cancer patients eligible for treatment with Roche's checkpoint inhibitor.
Eudamed Medical Device Database To Become Functional by 2024, EC Says
IVD and medical device manufacturers will need to transition to using Eudamed, a key feature of the EU's new IVDR, by 2026.