Class III medical devices in EUDAMED
Browse Class III medical devices registered in EUDAMED. Each result links to the manufacturer, certificates, and identifiers.
Class III is the highest-risk EU medical-device class, covering most implants and devices in contact with the heart or central nervous system.
1001 Class III medical devices in EUDAMED
Understanding Class III medical devices
Class III is the highest risk class under the MDR (2017/745), assigned via the rules in Annex VIII. It includes devices in contact with the heart, central circulatory system, or central nervous system, and most implantable and active implantable devices.
Conformity assessment
Class III devices always require Notified Body assessment. Certain Class III devices are additionally subject to the clinical evaluation consultation procedure, and a clinical investigation is generally required unless a justified exemption applies.
Frequently asked questions
What is a Class III medical device?
Class III is the highest risk class under the MDR (2017/745), including most implantable devices and devices in contact with the heart or central nervous system.
How is a Class III device certified?
Class III devices always require Notified Body assessment, and a clinical investigation is generally required unless a justified exemption applies.
Are Class III devices subject to extra scrutiny?
Certain Class III devices are subject to an additional clinical evaluation consultation procedure before certification.