HPO.TECH completes early EU MDR transition for hyperbaric chambers

HPO.TECH said Aug. 13, 2026, that it has moved its hyperbaric chamber systems from the EU Medical Device Directive to the stricter Medical Device Regulation. The early transition puts the Istanbul-based manufacturer on the current European rule set for clinical use, traceability and post-market oversight.

Why it matters: - The EU Medical Device Regulation now sets the standard for selling and using medical devices across Europe. - HPO.TECH’s early transition means its hyperbaric systems are already aligned with the newer rules for clinical evidence, traceability and post-market monitoring. - For hospitals and clinics, MDR certification can simplify procurement because one framework applies across all EU member states.

What happened: - HPO.TECH announced on Aug. 13, 2026, that it completed the transition of its hyperbaric chamber systems from the EU Medical Device Directive to EU MDR 2017/745. - The company said the move makes it an early dedicated hyperbaric chamber manufacturer to complete the shift. - The transition covers systems already installed and in clinical use across Europe.

The details: - MDR replaced the older directive with tighter rules for how medical devices are evaluated, documented and monitored. - The regulation requires stronger clinical evidence for intended use. - MDR also requires unique identifiers for traceability through the EUDAMED database. - Manufacturers must carry out continuous post-market surveillance for as long as the device remains in use. - EU lawmakers extended deadlines for legacy MDD certificates to 2027 and 2028 to reduce market disruptions. - HPO.TECH said completing the transition early indicates its systems already met MDR requirements without relying on the extended timeline. - Tolga Kabak, the company’s chief technology officer and co-founder, said: "MDR does not reward marketing. It rewards documentation." He said the company had to prove, unit by unit, that its chambers work as intended and can keep proving it throughout the product life cycle. - The company said MDR certification confirms a device meets EU requirements for safety, quality and performance for its intended use. - HPO.TECH said the certification allows its chambers to be placed on the market across all EU member states under a single framework. - The MDR transition adds to the company’s broader certification set, which includes ISO 13485, the Pressure Equipment Directive 2014/68/EU, ASME PVHO certification and UKCA marking.

Between the lines: - The move suggests HPO.TECH is positioning itself around compliance and documentation rather than waiting for regulatory deadlines. - In a crowded medtech market, early MDR completion can signal operational maturity and lower friction with procurement teams that want products aligned to current rules. - The company’s certification list also points to a strategy built around multi-market access, not only European sales.

What's next: - HPO.TECH said it is still pursuing additional clearances, including USA FDA, Philippines FDA, Vietnam DMEC, Hong Kong MDACS, Mexico COFEPRIS, Singapore HSA, Taiwan FDA and Japan PMDA. - The company will continue operating under the MDR framework for devices placed on the European market. - HPO.TECH, founded in 2020 in Istanbul, said it designs and manufactures hyperbaric, hypobaric and multibaric chamber systems for clinical, research, performance and wellness applications.

The bottom line: - HPO.TECH moved early to the EU’s stricter medical device regime, giving its hyperbaric chambers a regulatory position that matches current European market rules.