Class IIb medical devices in EUDAMED
Browse Class IIb medical devices registered in EUDAMED. Each result links to the manufacturer, certificates, and identifiers.
Class IIb is a medium-high-risk EU medical-device class assessed by a Notified Body.
1001 Class IIb medical devices in EUDAMED
Understanding Class IIb medical devices
Class IIb covers medium-high-risk medical devices under Annex VIII of the MDR (2017/745), such as long-term invasive devices and many devices that administer or exchange energy or substances with the body.
Conformity assessment
Class IIb devices require a Notified Body conformity assessment under MDR Annex IX (Chapters I and III), or alternatively EU type-examination under Annex X coupled with product conformity verification under Annex XI.
Frequently asked questions
What is a Class IIb medical device?
Class IIb covers medium-high-risk devices classified under Annex VIII of the MDR (2017/745).
How is a Class IIb device certified?
Class IIb devices require Notified Body assessment under Annex IX (Chapters I and III), or type-examination under Annex X with product verification under Annex XI.
What are examples of Class IIb devices?
Examples include many long-term invasive devices and devices that exchange energy or substances with the body.