Regulation
Class I medical device (MDR)
Lowest MDR risk class — self-declared, no Notified Body required in most cases.
Class I is the lowest risk classification under MDR. For most Class I devices the manufacturer self-declares conformity (no Notified Body assessment), though specific subclasses (Im, Is, Ir) require a Notified Body for parts of the assessment. Some ambient scribes hold Class I status (e.g. Stenoly).
Related tools
See also
- EU MDR (Regulation 2017/745) — EU Medical Device Regulation — governs healthcare software that has a medical purpose.
- Class IIa medical device (MDR) — Moderate-risk MDR class — Notified Body assessment and CE mark required.
- CE mark — Mark indicating an EU medical device has passed conformity assessment.