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 (Federal Institute of Metrology) involvement is typically required only for devices subject to legal metrology regulations (e.g., devices used for commercial or safety-critical measurements subject to Swiss metrology law). Most medical Class Im devices do not require direct METAS involvement; the NB performs metrological conformity assessment independently. Clarify with your NB whether METAS consultation is needed for your specific device type.
Official Sources
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