Class I medical devices in EUDAMED
Browse Class I medical devices registered in EUDAMED. Each result links to the manufacturer, certificates, and identifiers.
Class I is the lowest-risk EU medical-device class — most are self-declared by the manufacturer.
1001 Class I medical devices in EUDAMED
Understanding Class I medical devices
Class I covers the lowest-risk medical devices, classified by applying the rules in Annex VIII of the EU Medical Device Regulation (MDR 2017/745). Typical examples include many non-invasive devices and reusable surgical instruments.
Conformity assessment
Conformity for most Class I devices is self-declared by the manufacturer on the basis of technical documentation (Annexes II and III) together with an EU Declaration of Conformity. Class I devices that are sterile, have a measuring function, or are reusable surgical instruments additionally require Notified Body involvement limited to those specific aspects.
Frequently asked questions
What is a Class I medical device?
Class I is the lowest risk class under the MDR (2017/745), assigned using the classification rules in Annex VIII.
How is a Class I device certified?
Most Class I devices are self-declared by the manufacturer; sterile, measuring, or reusable surgical Class I devices need limited Notified Body involvement.
Are Class I devices in EUDAMED?
Yes. Class I devices and their manufacturers are registered in EUDAMED and searchable here.