The Omron HEM-7114 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 upper arm. It is intended for self-measurement and home use.

While the technology used in the Omron HEM-7114, 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 have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4, but there is no evidence provided on a validation of the other device.

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	While a clinical validation is claimed, it cannot be checked properly.
BP	Japanese Society of Hypertension	Self-measurement (Previous: 2016-2018)	Implied equivalence to the Omron M2 (HEM-7117-E), M3 (HEM-7200-E) or M6 (HEM-7211-E)