The new In Vitro Diagnostic Medical Devices Regulation (IVDR) EU 2017/746, was published in the Official Journal of the European Union in May 2017 with full implementation by the date of application, 25th May 2022. The new regulations will create an internationally recognised and robust, regulatory framework to improve clinical safety and market access.
Our CEO Seamus Kearney examines the changes in the new EU IVDR and how these will impact on the availability of precision medicine in the European Union.
For an overview of the transitional activities required under the IVDR and their status and what you will need to prepare for; download our whitepaper Implementing a CDx in your drug development programme.
ARC Insights offers a mix of industry specific content with the aim to keep its readers informed, educated, and up to date with the latest developments, trends, and expert knowledge in the FiH translational medicine space.
