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.

Achiko announced Tuesday that it has obtained the CE mark for its COVID-19 AptameX test and system, enabling its use in the European Union and other regions that accept the designation.

Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its portfolio of human leukocyte antigen (HLA) products.

The European Union’s In Vitro Diagnostics Regulation (IVDR) is set to take effect May 26, 2022, but a recent effort to amend the transitional provisions of the new regulation may bring some relief.

As a "visa" for products to enter the European market, CE certification is a mandatory requirement for product access in the EU market. From May 26, 2022, the European Union will begin to implement the In Vitro Diagnostic Medical Device Regulation EU 2017/746 (IVDR).