Current Edition

Are your Companion Diagnostic Partners Ready?

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. It is envisaged that the new regulations will create a robust, regulatory framework which will be internationally recognised to improve clinical safety and improved market access. It appears, however, that the majority of stakeholders are not ready for the increased challenges of obtaining and maintaining compliance to the new requirements. Seamus Kearney and Maud Smyth from ARC Regulatory reckon that the lack of clarity in some key aspects of the text means that many Rx/CDx sponsors are unsure of how to develop or move forward with their compliance plans.