The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...
News editors obtained the following quote from the background information supplied by the inventors: “Presently available in-vitro diagnostic (IVD) devices are used in various medical settings to ...
In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in ...
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 ...
DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer ...
ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) is seeking public comment on its draft framework, Real-World Clinical Evidence Generation: Advancing Regulatory Science ...
Framingham-based AB SCIEX, a global analytical technology company, announced the launch of a series of spectrometry-based systems for use in European clinical diagnostic laboratories, the company said ...
DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...
As part of EU efforts to provide guidance on the use of coronavirus tests, the JRC has created a database of COVID-19 in vitro diagnostic devices and test methods that gathers information on available ...
Medical Devices includes a session from a regulatory expert on how companies can align their research between regions.
Tempus AI Inc. shares rose after it said it received 510(k) clearance from the Food and Drug Administration for its RNA-based in vitro diagnostic device. Its stock recently rose 5.2% to $92.85 in ...