Microlife WatchBP Home A (BP 3MX1-3)
The technology used in the Microlife WatchBP Home A (BP 3MX1-3), 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| ESH (Europe) | Self-measurement | Published evidence | ||
| Stride BP | Self-measurement for adults and pregnancy (Preferred) | Equivalence claim without published evidence | ||
Chan PH, Wong CK, Pun L, Wong YF, Wong MM, Chu DW, Siu CW. Diagnostic performance of an automatic blood pressure measurement device, Microlife WatchBP Home A, for atrial fibrillation screening in a real-world primary care setting. BMJ Open. 2017 Jun 15;7(6):e013685. doi: 10.1136/bmjopen-2016-013685. PMID: 28619766. Available from: PMC5577883.
AFib validation
Willits I, Keltie K, Craig J, Sims A. WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2014 Jun;12(3):255-65. doi: 10.1007/s40258-014-0096-7. PMID: 24664995. Available from: PMC4026667.
The publication describes the use of the Microlife WatchBP Home A (BP 3MX1-3) in a scientific study.
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.
Microlife WatchBP Home (BP 3MX1-1)
Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol. Blood Press Monit. 2007 Jun;12(3):185-8. PMID: 17496469.
ESH-IP:2002 - Pass General population
Chung Y, de Greeff A, Shennan A. Validation and compliance of a home monitoring device in pregnancy: Microlife WatchBP home. Hypertens Pregnancy. 2009;28(3):348-59. doi: 10.1080/10641950802601286. PMID: 19263287.
BHS:1993 Pregnancy and pre-eclampsia (n=45; 15 pre-eclampsia) (Note: BHS results not in abstract)
Clark K, Snowball O, Nzelu D, Kay P, Kametas NA. Validation of the Microlife WatchBP Home blood pressure device in pregnancy for medium and large arm circumferences. Blood Press Monit. 2018 Jun;23(3):171-4. doi: 10.1097/MBP.0000000000000315. PMID: 29596069.
BHS:1993 - Pass (A/A) Pregnancy; Arm circumference 22 cm to 31 cm (n=51)
BHS:1993 - Pass (B/A) Pregnancy; Arm circumference 32 cm to 52 cm (n=46)
