O2 Concepts Receives Medical Device Regulation Certification

MIDDLEBURY, Connecticut—O2 Concepts, a provider of 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 (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 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 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, 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."

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

The company said it 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 durable medical equipment through durable delivery models, extended asset life and smart connectivity solutions to support evolving business models."