Medical devices class I m
Class Im (I measuring) is a subclass of Class I under MDR (EU) 2017/745. It covers Class I products that have a measuring function where the results are relevant for medical decisions.
Examples of Class Im products:
- Mercury thermometers (historical)
- Measuring lines and spatulas without other active components
- Rulers for physical measurements in medical settings
- Simple mechanical blood pressure devices (manometer-based)
- Involved exclusively for the aspect of measurement accuracy and calibration
- The rest of the product remains Class I and is conformity-assessed by the manufacturer independently
Practical relevance: for gloves and PPE, Class Im is rarely applicable. It is more commonly encountered in diagnostic aids and simple measuring instruments.
Distinction: a product with a measuring function may also fall into a higher class (IIa, IIb, III) if it scores higher through other characteristics (e.g. invasiveness, active components).
Frequently asked questions
What constitutes a measuring function under MDR Class Im?
A measuring function produces values used directly for medical decisions (diagnosis, therapy management). Simple visual scales (e.g. size markings) are not a measuring function in the sense of Class Im.
Why does the measuring function require a Notified Body?
Inaccurate measurements can lead to incorrect medical decisions. The MDR therefore requires independent assessment of metrological requirements by a Notified Body to ensure measurement reliability.
Are electronic thermometers Class Im?
Electronic thermometers can be Class Im if they have no other active components for other purposes. More complex digital thermometers with additional functions could fall into higher classes.