PRESS RELEASE FROM BIOIVT

BioIVT Supports In Vitro Diagnostic Device Manufacturers Seeking to Meet New European Market Regulatory Requirements

Posted Apr 26, 2021

BioIVT, a leading provider of research models and services for drug and diagnostic development, will discuss how it can help clients to meet the new EU regulatory requirements for in vitro diagnostic devices during a virtual Lunch & Learn session at 11 a.m. ET on April 27. The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), which replaces the EU In Vitro Diagnostic Medical Devices Directive (IVDD), will go into effect on 26 May 2022.

 

The IVDR ((EU) 2017/746) provides new definitions of an IVD and changes how they are classified, monitored, and regulated with the intention of improving the quality, safety, and reliability of IVDs. Under the new regulations most IVDs will require certification via a notified body. In many cases, this will require sponsoring manufacturers to conduct associated testing and analytics with specimens from clinical collections and/or clinical trials. 

 

“We are looking forward to showing how we can leverage our biospecimen procurement expertise, established collection/processing protocols, and data and sample validation experience, which we typically use to support clients’ diagnostic development, to progress IVDR validation and clinical evidence studies,” said Cathie G. Miller, PhD, Senior Director of Product Marketing, Personalized Medicine at BioIVT.

 

BioIVT Lunch & Learn presenters will include Jeffrey Widdoss, VP, Donor Center Operations; Darren Lowenthal, VP, Disease State Diagnostics; Kelly Sapsford, Head of Donor Center Operations, EU; and Tanya Orenstein, Clinical Operations Manager. They will also be available to answer questions about specific biospecimen solutions.

 

Interested persons can register for this complimentary event at http://bit.ly/BioIVTIVDR.

 

About BioIVT

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit www.bioivt.com or follow the company on Twitter @BioIVT.