The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical ...

In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

Ohaus Corporation introduces its latest Frontier IVD centrifuge range, combining high-performance laboratory separation with eco-conscious design. Built to meet the rigorous requirements of ...

PARIS – The CE mark is dead, long live the new CE mark. Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council ...

Mechelen, Belgium, 10 March 2026 – Today, Biocartis announced that its Idylla™ CDx MSI Test has received Class C companion diagnostic ( CDx) certification under the EU’s IVDR1 as a CDx for colorectal ...

Independent clinical validation strengthens ABL’s leadership in the fast‑growing HIV drug‑resistance testing market ABL ...