RISE MNB applies to become a Notified Body for IVDR

RISE Medical Notified Body AB (RISE MNB) is pleased to announce that we are now applying to become a Notified Body for IVDR (EU) 2017/746. Currently, Sweden lacks a Notified Body for IVDR products, which means that manufacturers need to turn abroad for certification. RISE MNB can thus become the first – and only – Swedish company with the ability to offer review and certification within the country, where documentation can be handled in both Swedish and English.

Since March 2024, RISE MNB has been a Notified Body for the Regulation (EU) 2017/745 on Medical Devices (MDR). "The fact that we are now moving forward with IVDR is a natural step in our development and will strengthen us in our mission as a notified body and contribute to a competitive and innovative business community. We believe that we can learn many lessons from the transition from MDD to MDR now that IVDD is transitioning to IVDR and affected companies are facing similar challenges – both nationally and at the EU level," says RISE MNB CEO Åsa Betten.