Medical Device Vigilance: Important Considerations to Comply With the EU MDR
Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
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admin.veranex : Mar 24, 2025 10:23:08 PM
By developing a cost-effectiveness model and associated manuscript for home non-invasive ventilation in patients with persistent hypercapnia after an acute exacerbation of COPD, Veranex bolstered the economic argument for home non-invasive ventilation in the UK. The cost-effectiveness analysis was based on clinical trial data from a multi-center study coordinated by Guy’s and St Thomas’ NHS Foundation Trust in London that showed improved survival with home non-invasive ventilation (Murphy PB, Rehal S, Arbane G, et al. Effect of home noninvasive ventilation with oxygen therapy vs oxygen therapy alone on hospital readmission or death after an acute COPD exacerbation: a randomized clinical trial. JAMA 2017;317:2177–86. https://jamanetwork.com/journals/jama/fullarticle/2627985). A similar cost-effectiveness analysis from a US perspective, included as a supplement, demonstrated that home non-invasive ventilation is also cost-effective in the United States.
Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
5 min read
Bob BouthillierDirector, Electrical Engineering, Veranex In this post, our director of electrical engineering Bob Bouthillier...