The regulatory interplay between medical devices and medicines – focus on companion diagnostics in the EU and U.S.(Part 2)

Companion diagnostics are classed in the U.S. and in the EU as medical devices, usually in-vitro medical devices (IVDs). They are a class of products which are rapidly gaining in importance, particularly in treating patients with cancer. About one third of marketing authorisations in the field of oncology in the EU between 2010 and 2020 required a diagnostic test for patient identification. The Global Oncology Companion Diagnostic Market Size was valued at 2.2 billion in 2019.     In this podcast, Sapna Palla, Tine Carmeliet and Rafi Allos discuss the regulation of IVDs in the EU and the U.S. and how they are authorised in these jurisdictions.