RAPS

GHTF Changes Definitions of 'Medical Device' and 'IVD'

The Global Harmonization Task Force (GHTF), an international harmonization body whose duties are soon to be subsumed by the International Medical Devices Regulators' Forum (IMDRF), has released a ...
RAPS

MHRA wants feedback on updating IVD, medical device regulatory framework

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has wants public input on reforming its regulatory framework for medical devices and in vitro diagnostics (IVD). MHRA has opened ...
Business Wire

Veranex Acquires Devicia and Clarvin, Expanding Regulatory, Quality, and Clinical Expertise for IVD and Medical Devices

RALEIGH, N.C.--(BUSINESS WIRE)--Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced today that it has acquired an ...
News Medical

Navigating IVD compliance with IVDR and Indian MDR standards

HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...
Labroots

IVD Versus RUO in The Clinical Laboratory

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...
Business Wire

Medical Device Innovation Consortium Releases Real-World Evidence Framework for In Vitro Diagnostics

ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics ...
360Dx

European Notified Bodies Raise Alarms Around IVDR Revision as Submissions Decline

Notified bodies have been warning in recent weeks that the envisioned changes to the regulation might create new headaches for IVD makers in Europe.
JD Supra

MHRA opens consultation on future routes to market and IVDs under the UK medical device regulations

The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals ...
BioWorld

FDA finalizes IVD, medical device software guidance

The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...
GEN

The Bioethics of IVD Devices and Informed Consent Issues

More Lenient Guidelines May Inadvertently Lead to a Scarcity of Consented Samples Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing ...
JD Supra

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition ...