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CATEGORY: CLASSIFICATION
Class I Medical Device
The lowest risk category of medical devices. In the US, most Class I devices are exempt from 510(k). In the EU, Class I devices can be self-certified by the manufacturer without Notified Body involvement (except for sterile, measuring, or reusable surgical devices).
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Class I devices are lowest risk. Many US Class I devices are 510(k)-exempt; EU Class I may be self-declared except sterile/measuring/reusable surgical variants needing NB involvement.
PROCESS / STEPS
- Confirm classification and exemptions.
- Implement proportionate QMS and labeling.
- Register/list as required (US establishment registration/device listing).
- Monitor postmarket complaints even for low-risk devices.
EXAMPLES
- Elastic bandages and many manual instruments are typical Class I examples (check current product codes).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Class I Medical Device across 27 authorities in real time.
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