The BTL Cardiopoint BTL-08 ABPM (V1) is an ambulatory 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 ambulatory blood pressure monitoring.

While the technology used in the BTL Cardiopoint BTL-08 ABPM (V1), 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 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
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	ABPM	Manufacturer declaration of equivalence to a device without published evidence
BP	ESH (Europe)	ABPM	The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.