JD Supra

The use of IVDs as CDx in pharmaceutical clinical trials - Pathways for legacy companion diagnostic IVDs, IVD performance studies, and in-house IVDs

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 ...
JD Supra

Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"?

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 ...
RAPS

IVDs Top the List of Devices Seeing Field Safety Corrective Actions, Report Shows

More field safety corrective actions (FSCAs) were issued for in vitro diagnostic (IVD) devices than any other device types in the first half of 2019, according to a report published Monday by UK-based ...
RAPS

MHRA proposes requirements for high-risk IVDs

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is proposing significant changes to its regulations for certain high-risk in vitro diagnostics (IVDs). The agency has opened a ...