Regulatory Statement & Conformity

MDR Statement

QUMEA Care is not a medical device according to Regulation (EU) 2017/745 and therefore does not fall within its scope of the same.

QUMEA Care is intended for the prevention of injuries. According to Article 2 paragraph 1 of Regulation (EU) 2017/745 (European Union Medical Device Regulation - MDR), the prevention of an injury is not a medical purpose. The movement and activity data as recorded and displayed by QUMEA Care are ultimately intended to be used to prevent injuries. The device is not intended to be used for "diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury" and accordingly, not for a specific medical purpose.

QUMEA Mobility Sense is a Class 1 medical device according to Regulations (EU) 2017/745 (European Union Medical Device Regulation - MDR) and MepV (2020/812.213).

QUMEA Mobility Sense is intended to be used for prevention of Decubitus ulcers and pressure areas (ICD L89). The product is solely used to inform the caretaker when a patient did not show a certain level of mobilization for a specific amount of time. The required level of mobilization is defined as a change in posture of the recumbent subject (e.g. turning from supine to lateral position). No diagnostic or therapeutic decisions can be made based on the output of the data.

Conformity (CE)

QUMEA sensor products are in conformity with European health, safety, and environmental protection standards.

QUMEA AG CHRN: CHRN-MF-20002870

Classification and conformity documentation, as well as additional documents, are available upon request from QUMEA AG.

Disclosure

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