Keeler Big Ben Round
While the technology used in the Keeler Big Ben Round, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.
|Medaval||None||This is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Professional use||Manufacturer declaration of equivalence to a device without published evidence|
|ESH (Europe)||Professional use||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|