O2 Concepts® Obtains MDR Approval for the European Union, Expanding Global Reach of Its Portable Oxygen Solutions

Middlebury, Connecticut, July 16, 2025 — O2 Concepts®, a leading innovator in portable oxygen concentrators (POCs), has received Medical Device Regulation (MDR) certification, which grants approval to market and distribute its Oxlife Liberty® POC and Oxlife Independence® POC with DNA Technology across European Union (EU) member countries.  

EU Regulation 2017/745 (MDR) is the European Union’s revised regulatory framework governing the safety, performance, and quality of medical devices, and replaces the former Medical Device Directive 93/42/EEC (MDD). MDR introduces more rigorous standards for clinical evaluation, post-market surveillance, traceability and transparency. MDR certification expands the O2 Concepts’ POCs available to carry the CE mark, a requirement for sale in EU markets. 

With O2 Concepts’ MDR certification, the Oxlife Liberty and Oxlife Independence portable oxygen concentrators meet Europe’s most rigorous medical device standards — ensuring healthcare providers and patients have access to portable oxygen solutions they can trust.

"For us, MDR approval is more than expanding into new markets — it is a reflection of our company’s high standards for our POCs in clinical efficacy and reliable performance,” said Elby Beal, CEO of O2 Concepts. “We are in the innovation business, designing and building advanced portable oxygen devices that perform better and over a longer term for our customers and patients." With MDR approval in Europe and recent MDSAP approval for Health Canada, the company is well-positioned to meet growing global demand for its portable oxygen solutions

To support its European expansion, O2 Concepts is partnering with leading distributors to bring Oxlife devices to high-demand EU markets. With MDR approval in Europe and recent MDSAP approval  for Health Canada, the company is well-positioned to meet growing global demand for its portable oxygen solutions.

While other manufacturers have scaled back or moved production to Asia, O2 Concepts continues to invest, innovate, and deliver from its US facilities to a broadening international market. The company remains committed to delivering the most technologically advanced, dependable, and clinically driven POCs that support patient mobility and independence, while delivering long-term value for DMEs through durable delivery models, extended asset life, and smart connectivity solutions to support evolving business models.

About O2 Concepts®

O2 Concepts was created from the belief that patients who need oxygen therapy deserve better — better than bulky tanks, cumbersome carts, and the limited mobility that traditional therapies often impose. As a pioneer in portable oxygen concentrators, O2 Concepts devices are engineered to be intentionally portable and deliver years of reliable 24/7 performance. Enabled with DNA Technology®, O2 Concepts’ proprietary intelligent network, its devices empower providers with device-initiated remote asset and clinical monitoring, unlocking new levels of efficiency, improved outcomes, and DME profitability. Trusted by leading academic and research medical centers, O2 Concepts’ devices are used by healthcare systems and homecare providers throughout the United States and now expanding its European and Canadian presence to deliver the best long-term oxygen therapy for their patients.

For more information, contact us.