Class I medical devices with measuring function

Class I devices with a measuring function need a notified body for the aspects related to metrology, unlike other class I devices. Measurements must be expressed in legal units, as noted in Annex I section 15.2.

Class I medical devices with measuring function - are considered Class I medical devices which measure physiological parameters or anatomical parameter or energy, respectively, or volume of medicinal products, body liquids or other substances administered to or removed from the body and display or indicate its value in a unit of measurement (example: urine bags, non-active thermometers, measuring spoons). Note: According to section 15.2 of Annex I, measurements made by devices with a measuring function will be expressed in legal units.

MDCG 2019-15 Rev.1, Definitions