The CE mark also allows Medtronic’s automated insulin delivery system to be used during pregnancy and by children as young as ...

Biolog Enters the European Diagnostic Market, Bringing 45 Years of Anaerobic Culture Excellence Biolog, a leading provider of microbial identific ...

The LENNY trial highlighted the system's efficacy and safety in children aged two to six years with type 1 diabetes.

Under IVDR 2017/746, the Performance Evaluation Report (PER) is a critical component of the technical documentation required for CE marking of In Vitro Diagnostic (IVD) devices.

Medtronic said its market-leading LigaSure technology can now be used with its Hugo soft tissue robotic surgery system in ...

The CE mark suspension isn’t the first setback the pumps have faced in recent months. In December, Getinge began a recall of the pumps that was ultimately given the FDA’s most serious Class I ...

LumaCyte recently won CE marking for its label-free, single cell analysis instrument, Radiance ®. This EU specific regulatory standard is only conferred on instrumentation or devices after a ...

Key Highlights The UKCA mark was introduced in the Great British (GB) market to replace the European CE mark following Brexit. Products which require a CE mark in the EU must comply with the UKCA ...