Beurer BM 40 - Medaval

Description:

The Beurer BM 40 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.

Assessment:

While the technology used in the Beurer BM 40, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified. It has also been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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.
BP	DHL (DE)	General use (Latest: 2014)	Unpublished internal data
BP	Stride BP	Self-measurement for adults (Previous) (Preferred)	Equivalence to the Sejoy Joytech DBP-1307 claim without published evidence

Device Family:

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.

Sejoy Joytech DBP-1307 (Sejoy BP-1307, Joytech DBP-1307)

Lei L, Chen Y, Chen Q, Li Y, Wang JG. Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2017 Dec;22(6):371-4. Epub: 2017 Aug 03. doi: 10.1097/MBP.0000000000000283. PMID: 28786853 .

ESH-IP:2010 - Pass General population