Class IIa medical devices in EUDAMED
Browse Class IIa medical devices registered in EUDAMED. Each result links to the manufacturer, certificates, and identifiers.
Class IIa is a medium-low-risk EU medical-device class assessed by a Notified Body.
1001 Class IIa medical devices in EUDAMED
Understanding Class IIa medical devices
Class IIa covers medium-low-risk medical devices under the classification rules in Annex VIII of the MDR (2017/745) — generally short-term or surgically invasive devices and many active devices.
Conformity assessment
Class IIa devices require a Notified Body conformity assessment under MDR Annex IX (Chapters I and III), or alternatively conformity assessment based on technical documentation (Annexes II and III) combined with Section 10 or Section 18 of Annex XI.
Frequently asked questions
What is a Class IIa medical device?
Class IIa covers medium-low-risk devices classified under Annex VIII of the MDR (2017/745).
How is a Class IIa device certified?
Class IIa devices require Notified Body assessment under Annex IX (Chapters I and III) or an alternative route based on technical documentation with Annex XI.
What are examples of Class IIa devices?
Examples include many short-term surgically invasive devices and a range of active devices.