Ergoline Ergoscan
While the technology used in the Ergoline Ergoscan, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | ABPM | Manufacturer declaration of equivalence | ||
| ESH (Europe) | ABPM | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
EnviteC PhysioQuant ABPM (45-00-0500)
Langewitz W, Tanner S. Validation of the PhysioQuant blood pressure measuring monitor in adults. Blood Press Monit. 2009 Oct;14(5):220-1. doi: 10.1097/MBP.0b013e328330c830. PMID: 19704372.
ESH-IP:2002 - Pass General population
