Medical Devices Classification EU MDR - devices with a measuring function


Hi, does anyone know if there is a list that specifies what is considered as 'an anatomical or physiological parameter'? We are being challenged by a competent authority around the classification of a new device (proposed as a Class I accessory) who state that the detection of pressure changes while inhaling a medication (only possible while inhaling a medicine, using our device) is a physiological parameter. It is not the intended use nor is it possible to detect 'normal' inhalation rate with the product. Thank you.


Involved In Discussions
Hi, I'm not sure how your device works, anyway, MDCG 2021- 24 states that "Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia, intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as part of routine checkups or self-monitoring are in class IIa." and that electronic blood pressure measuring equipment are in class IIa.

Rule 10, page 42

Raisin picker

Quite Involved in Discussions
I doubt there is a list. You can, however, take a look at the borderline manual to get an idea of the thinking there. There are older versions of the manual, but mostly dealing with MDD.
Top Bottom