Are You Ready for the In Vitro Diagnostics Regulation (IVDR)?
Recommendations on meeting the IVDR
Authors: Caroline Freeman, Principal Consultant, IQVIA, Michael Wienholt, Regulatory Director, Q2 Solutions, & Alan Wookey, Companion Diagnostics & Oncology Scientific Advisor, Q2 Solutions
Regulations around in vitro diagnostic products (IVDs) are designed to assure safety and effectiveness, leading to improved health of patients. The IVD regulation, or IVDR, has led to changes in the way that the European Union regulates IVDs and the challenges these changes pose to manufacturers. While the principles of the requirements will be familiar to manufacturers that already have products on the market, there will be challenges in meeting the IVDR. This white paper reviews recent changes and provides recommendations for actions to be compliant within the timelines. It addresses requirements on companion diagnostics (CDx), and also looks at opportunities to consider when partnering with a global central laboratory for IVD / CDx development.
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