Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR).

Thermo Fisher Scientific said on Thursday that its Exent Solution, an automated mass spectrometry system for diagnosing patients with monoclonal gammopathies, including multiple myeloma, has been approved under Europe's In Vitro Diagnostics Regulation.

Devyser’s novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplant patients fulfill IVDR requirements in Europe.

Recently, Ustar and Hangzhou Biotest Biotech received the IVDR CE certificate from TÜV SÜD, a notified body designated under the EU's IVDR.

Oxford Gene Technology announced that eight of its CytoCell fluorescence in situ hybridization probes have been certified for clinical use in line with Europe's In Vitro Diagnostics Regulation (IVDR).

MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).

QIAGEN N.V. today announced the certification of QuantiFERON-TB Gold Plus (QFT-Plus) – the world’s leading tuberculosis (TB) blood test – under the European Union’s 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR) which is replacing the 98/79/EC In Vitro Diagnostic Directive (IVDD).

Ibex Medical Analytics has received CE mark for its pathology diagnostics platform, Galen Prostate, under the European Union’s (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR).

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. obtained the CE extension certificate issued by TüV SüD, a famous EU notified body under the IVDR regulations.

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done.