Vital physiological processes and parameters

Under MDR Annex VIII rule 10, monitoring vital physiological parameters can raise an active diagnostic device to class IIb when variations could cause immediate danger. Rule 11 for software uses similar wording.

Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature.

MDCG 2021-24 Rev.1, Section 4.2, Rule 10, Practical issues of classification, Note 3