Medical Device Classification Class Im

Medical Device - Class Im (Measuring Device)

Criteria for determining devices with measuring function.

The following criteria, if fulfilled together, indicate that a device has a measuring function:

  • The device intended to measure, quantitatively a physiological or anatomical parameter, or - a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body.
  • The result of the measurement is displayed in legal units or other acceptable units within the meaning of Directive 80/181/EEC or is compared to at least one point of reference indicated in legal units or other acceptable units in compliance with the pre-mentioned Directive.
  • The intended purpose implies accuracy, claimed explicitly or implicitly.

Measuring activities during the manufacturing process including those for calibration purposes are not covered by this recommendation and do not imply a measuring function of the manufactured device.

Examples for Class I devices with a measuring function:

  • Non-active device for measuring body temperature.
  • Pacifier which includes a non-active temperature display.
  • Device for indicating that body temperature is above or below a specified value.
  • Non-active non-invasive device for measuring blood pressure.
  • Non-active device for measuring intraocular pressure.
  • Device for measuring volume or flow of liquid or gases delivered to or removed from the human body.
  • Device for the delivery of liquid to the human body (e.g. medicine spoons, cups, droppers, without graduation or scale).
  • Device for displaying trends of physiological parameters (e.g. urine drainage bags without graduation or scale, calipers for obesity).
  • Eye-test chart

Note :- it is assumed that the relevant classification rules permit classification in Class I, provided that relevant criteria are met.

  • Class 1 Device with measuring function are packed and supplied in a sterile condition require Notified Body Certificate, whereas the non-sterile class 1 measuring device do not!
  • ISO 13485 is Voluntary

More details about CE Certification Process click here .