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Reliable service

TÜV NORD Scandinavia Medical Notified Body AB

RISE MNB is your personal partner on the road to market access in the EU.
Discover our MDR certification
Globalt nätverk och kommunikation
TÜV NORD Scandinavia MNB – part of the TÜV NORD GROUP
As part of the global TÜV NORD GROUP, TÜV NORD Scandinavia MNB offers medical certification and conformity assessment services.
More about the TÜV NORD GROUP

With patient safety in focus

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.

MDR 2017/745 and ISO 13485

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

Additional information

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

Contact us!

Are you interested in learning more about a specific topic? Feel free to contact us!