An EU Company Perspective From Omega Diagnostics
Executive Summary
Omega Diagnostics' Michael Gordon explains why the EU IVD market is likely become much more challenging soon – and not always for the right reasons.
You may also be interested in...
IVD Companies Brace For EU Regulatory Changes
The proposed EU In Vitro Diagnostics Regulation will introduce a tougher system of regulation that will bring increased intervention of notified bodies into the compliance pathway. Companies selling IVDs into the EU market are beginning to factor in rising costs and other challenges before it takes effect.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.