Monivent receives MDR certification for Neo100

Neo100 was previously CE marked under the Medical Device Directive (MDD), the regulatory framework that preceded the MDR. Monivent submitted its application for MDR certification to BSI in 2023 and has since undergone an extensive regulatory review process, including comprehensive assessments of the product’s technical and clinical documentation, additional testing and the submission of supplementary documentation to demonstrate compliance with the more stringent requirements introduced under MDR.

Beyond enabling the planned European launch, the transition to MDR provides a robust regulatory framework for the continued development of Neo100 and for implementing future product improvements, including those based on customer feedback from the product’s first years on the market. MDR certification may also facilitate regulatory pathways in certain markets outside the EU, including Australia. Monivent intends to actively evaluate opportunities for additional market registrations.

“Receiving MDR certification is a major milestone for Monivent and the result of several years of intensive work by the entire team. Most importantly, it clears the regulatory path for the planned European launch of Neo100 together with Dräger and marks the beginning of an important new commercial phase for Monivent” says Maria Lindqvist, CEO of Monivent.