Recently, Autobio's thyroid functional magnetic particle chemiluminescence series reagents obtained the EU IVDR CE certification issued by TüV SüD. This is the first series of Autobio’s products to obtain the EU IVDR CE certification.

The European Union's in vitro diagnostic expert panel has published its first opinion on an In Vitro Diagnostic Medical Devices Regulation (IVDR) submission, delivering a glowing opinion of the filing for a test to screen plasma donor samples for hepatitis E virus (HEV).

The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics for products that still need assessment of a notified body.

Recently, TÜV SÜD Product Service GmbH an EU Notified Body certified the first IVDR CE certificate in the field of chemiluminescence in China, and its winner is Shenzhen New Industries Biomedical Engineering Co., Ltd.