Visomat Comfort
While the technology used in the Visomat Comfort, 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.
| 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) | Self-measurement | Implied equivalence to the Visomat Comfort Form | ||
| ESH (Europe) | Self-measurement | 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.
Visomat Comfort Form (v1)
Bonso E, Dorigatti F, Saladini F, Palatini P. Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol. Blood Press Monit. 2010 Feb;15(1):63-6. doi: 10.1097/MBP.0b013e32833531de. PMID: 20075716.
ESH-IP:2002 - Pass General population
