ABSTRACT
The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both the manufacturer and notified body, which give insight into the nature of their review processes. In 2022, Regulation (EU) 2022/123 gave responsibility for the oversight of those expert panels to the EMA. This move suggests a more active role for the EMA in the approval of medical devices in ways that will impact future device submissions. The additional review will bring a new level of complexity and criticism into an already strained review process. Copyright © 2022, TOPRA. All rights reserved.