The technology used in the Medel Replay, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
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.
Zaetta V, Longo D, Perkovic D, Perfetti P, Gabrieli A, Pratticò F, Winnicki M. Validation of the SAW-102 wrist home blood pressure monitor according to the protocols of the British Hypertension Society, the Association for the Advancement of Medical Instrumentation, and the European Society of Hypertension. Blood Press Monit. 2009 Feb;14(1):32-6. doi: 10.1097/MBP.0b013e3283105496. PMID: 19262198.
ESH-IP:2002 - Pass General population
BHS:1993 - Pass (B/B) General population
SP10:1996 - Pass General population