IVD

Randox is using the funding, which includes £23 million from Invest NI, to create three centers in Northern Ireland to develop new diagnostic technologies.

MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.

The group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.

The agency cleared the company's C-reactive protein, which is based on its Multi-Array technology used by life science researchers for 20 years. 

The base term for the contract, which is for medical surgical products, is 14 months with eight one-year and one 10-month option periods.

The hospital will run Agendia's new NGS test kit in its lab, comparing results with the firm's existing centralized MammaPrint test.

The new draft guidance is expected to reduce study-related costs and save time for manufacturers of certain classes of in vitro devices.

The company discussed expectations for how its products will fare against rivals into next year based on recent data and coverage decisions, and on expected reimbursement changes.

While stakeholders hope that the country will continue to accept the CE-IVD mark after Brexit, the issue is unresolved, leaving firms in the dark as to what the future may bring.

The FDA cited Euro Diagnostica for at least five violations stemming from an inspection of its facility in January, as well as inadequate responses to those violations.  

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