RISE Medical Notified Body AB
Welcome to RISE Medical Notified Body
RISE Medical Notified Body (RISE MNB) is designated as a notified body for medical devices under MDR 2017/745.
- We accept applications and documentation in Swedish and English
- We communicate in Swedish and English
All medical devices placed on the European market must first meet the requirements of MDR 2017/745 and then be CE marked by the manufacturer. When a medical device has a class higher than Class I, a conformity assessment must be carried out by a notified body under MDR 2017/745.
RISE MNB carries out conformity assessments procedure for class Is, Im, Ir, IIa and IIb.