Grandway MD2200-BK

Description:

The Grandway MD2200-BK is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Grandway MD2200-BK to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.

Device Family:

Grandway MD2200-W (G.LAB)Z, Grandway MD2200-BKZ
Legend: Z Almost Certain

Validation Publications for Equivalent Devices:

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.

Grandway MD2200-W (G.LAB)

Liu ZY, Zhang QH, Ye XL, Liu DP, Cheng K, Zhang CH, Wan Y. Validation of the G.LAB MD2200 wrist blood pressure monitor according to the European Society of Hypertension, the British Hypertension Society, and the International Organization for Standardization Protocols. Blood Press Monit. 2017 Apr;22(2):101-4. Epub: 2017 Feb 7. doi: 10.1097/MBP.0000000000000234. PMID: 28177942.

ESH-IP:2010 - Pass General population

81060-2:2013 - Pass General population

BHS:1993 - Pass (A/A) General population