A Notified Body is approval is required for higher risk medical and IVD devices in the EU. This business relationship is intended to be long-term and it’s best to be prepared.
UL Notified Body staff have collaborated on an article titled “Critical Things to Consider When Looking for a Notified Body” that lists the top 11 things companies should be asking their prospective Notified Body.
You can access the complimentary article at: http://connect.ul.com/HS-ML-New-Article—Transfer-Notified-Body_04—LP-Registration.html
If you have any questions about UL’s Notified Body or would like to contact us for more information, please email us at: Medical.Inquiry@ul.com.