TÜV NORD Scandinavia MNB is your personal partner on the road to market access in the EU. We provide comprehensive support for the development and innovation of medical devices. As a manufacturer, you can expect a customer-focused relationship characterized by excellent availability and communication, along with a clear and efficient certification process.
RISE MNB is a notified body for medical devices according to MDR 2017/745, as well as accredited for certification according to ISO 13485. We carry out conformity assessment of medical devices within several product groups, including:
Software
Devices with a measuring function
Medical aids
Dental products
Sterile products
We handle products of risk classes Is, Im, Ir, IIa and IIb. You can find you codes here.
TÜV NORD Scandinavia MNB handles applications, documentation and communication in Swedish and English. You can contact us anytime!
If you want to change your notified body to TÜV NORD Scandinavia MNB you will find information about voluntary change here.