O2 Concepts, manufacturer of portable oxygen concentrators (POCs), has announced that it’s received Medical Device Regulation (MDR) certification, clearing the way to market and distribute the company’s Oxlife Liberty POC and Oxlife Independence POC with DNA Technology in European Union member countries.
“MDR certification expands the O2 Concepts’ POCs available to carry the CE mark, a requirement for sale in EU markets,” the company said in a July 17 press release. “With O2 Concepts’ MDR certification, the Oxlife Liberty and Oxlife Independence portable oxygen concentrators meet Europe’s most rigorous medical device standards — ensuring health-care 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, O2 Concepts’ CEO. “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.”
O2 Concepts’ announcement added, “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 U.S. 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 [durable medical equipment providers] through durable delivery models, extended asset life, and smart connectivity solutions to support evolving business models.”
The company added, “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.”
O2 Concepts is headquartered in Oklahoma City, Oklahoma. Manufacturing, service, research and development, and customer/tech support are based in Middlebury, Connecticut.
