Measuring Devices (Class Im)
Overview
Class Im devices have a measuring function used for clinical purposes. Examples include clinical thermometers, blood pressure monitors with diagnostic indication, and calibrated measurement systems. Class Im requires NB involvement for the metrological aspects of conformity assessment.
Metrological Requirements
The NB assesses conformity of Class Im devices with the provisions of MedDO Annex IV relating to metrological requirements. These cover: accuracy of measurement; calibration traceability; measurement uncertainty; drift and stability over the device's expected lifetime.
METAS Interface
METAS (Federal Institute of Metrology) may be relevant for certain measuring devices, particularly those with claims relating to legal metrology or devices that interact with regulated measurement infrastructure. Check whether METAS involvement is required for your specific device type.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.