This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).
Manufacturers are expected to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged to reflect the most current best-practice science. To establish that your IVD is SOA, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA.
Knowing what the Notified Body expects to see will help you avoid …
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.
Get a copy of the slides from this webinar or click to watch the recording.
In this live discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
Who are the panelists?
Laurie Mitchell, President | Criterion Edge
Caroline Byrd, VP of Regulatory, Quality, and Clinical | Nextern
Dr. Krishna Sudhir, Divisional VP, Medical Affairs and Product Performance | Abbott Vascular
Sidney Collin, Cofounder and CEO | De Oro Devices
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Author: Suzanne Broussard, PhD | June 8, 2021
In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification will require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.
Here we share our insights learned from writing many MDR-compliant Clinical Evaluation Reports (CERs) in the context of IVD medical devices and the looming IVDR deadline.
(more…)The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.
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