The session opened with an overview of the European regulatory pathways for medicinal products and medical devices (MD)/ in vitro diagnostics (IVDs) by Stiina Aarum. While the EMA reviews the marketing authorisation for a medicinal product, MD/IVD are assessed by a notified body (NB) of choice. For medicines used in combination with a MD, the EMA will assess safety and efficacy of the medicine used in combination with the device as part of the marketing authorisation application (MAA).