The medical technology company Monivent has received feedback from its notified body, BSI, in the ongoing MDR review of Neo100. BSI is requesting certain additional clarifications and product documentation for remaining questions, but the company states that the feedback is fully in line with expectations. Monivent therefore still assesses that MDR approval can be obtained during the second half of 2026, when the European launch together with Dräger is also expected to begin. MDR approval is required to retain the CE marking after 2028.