EU MDR Compliance

Effective date: September 15, 2025.

As part of Regulation (EU) 2017/745 on medical devices (MDR), Beyond Air provides electronic access to the Operator’s Manual for our CE-marked device, LungFit® PH.

This documentation is available in PDF format and includes the most current, approved version.

This documentation is also intended for our current partners. If you are a current partner and would like to access it, please reach out to your Beyond Air representative for the password. 

Download the LungFit® PH Operator's Manual (EU) (20071 v6 March 2025)