EU-MDR Certification: Meeting the European Standard in Hyperbaric Oxygen Therapy
HPO.TECH has completed the transition of its hyperbaric chamber systems from the EU Medical Device Directive to the EU Medical Device Regulation, becoming the first dedicated hyperbaric oxygen therapy manufacturer to do so. For anyone who buys, operates, or is treated in a hyperbaric chamber, this development is important, as it allows you to operate our devices legally in a medical setting all around Europe.
What is the EU-MDR certification?
The Medical Device Regulation, formally Regulation (EU) 2017/745, is the law that governs medical devices sold in the European Union. It replaced the Medical Device Directive (MDD, 93/42/EEC), which had been the reference framework since the 1990s. MDR now sets the requirements every device must meet to carry a CE mark and be placed on the European market.
The shift from a directive to a regulation means we now have a singular standard across the European Union, as opposed to variations in the local legislation of each member state. A directive lets countries translate the rules as they see fit. A regulation applies directly and identically across every member state.
Why is the regulation better than the directive?
MDR was written in response to a straightforward criticism of the old system: a device could clear the bar at market entry and then face relatively little scrutiny afterward. The regulation closes that gap in three main ways:
- It asks for stronger clinical evidence. A manufacturer has to demonstrate, with data appropriate to the device and its intended purpose, that the device performs as claimed and is safe to use.
- It asks for traceability. Every unit carries a Unique Device Identifier and is registered in EUDAMED, the European database, so a specific chamber can be tracked from factory to clinic.
- And it asks for continuous post-market surveillance. The manufacturer’s duty does not end at the sale. It continues, with structured monitoring and reporting, for as long as the device is in clinical use.
The move to EU-MDR has been one of the harder passages in recent European medtech.
The requirements are heavier, the notified bodies that assess devices are fewer and more stretched than before, and the technical documentation involved is substantial. To keep compliant devices from dropping off the market during the changeover, EU lawmakers extended the deadlines for legacy MDD certificates to 2027 and 2028. Many manufacturers are still working through that extended runway.
Completing the transition now, rather than relying on the extra time, indicates that a manufacturer’s systems already met the regulation’s requirements. For us at HPO.TECH, that’s the point. Our chambers did not have to be reworked to pass. They were engineered to a standard the regulation has since made mandatory.
What does this mean, in practice, for HPO.TECH?
Beyond the European Union, MDR certification also expands HPO.TECH’s international regulatory reach. Together with a Certificate of Free Sale, it supports streamlined registration pathways across much of Southeast Asia, the Gulf region, Latin America, Africa, and EU-aligned European markets, including countries such as Malaysia, Indonesia, Pakistan, Egypt, Mexico, Colombia, Chile, Switzerland, and the Western Balkans.
While local registration remains necessary, MDR serves as the principal reference standard for market access in many of these jurisdictions.
Where does MDR fit in HPO.TECH’s certification set?
MDR joins a broader set of clearances the company holds, among them ISO 13485 for medical-device quality management, the Pressure Equipment Directive (PED 2014/68/EU), ASME PVHO certification for pressure vessels for human occupancy, UKCA marking for the United Kingdom, ASME U-Stamp, SFDA, UAE MOH+EDE, Medsafe New Zealand, Thai FDA, GHANA FDA, and ISO 9001. Moreover, the company is in the process of obtaining USA FDA, Philippines FDA, Vietnam DMEC, Hong Kong MDACS, Mexico COFEPRIS, Singapore HSA, Taiwan FDA, and Japan PMDA.
Read together, they describe a device evaluated and certified as both a medical product and a pressure system, in many countries and jurisdictions. For a field still moving through the EU-MDR transition, HPO.TECH reaching the far side of it early is a marker of where its engineering already stood.
Certifications
HPO TECH hyperbaric chambers comply with a wide range of international regulatory standards to ensure safety, quality, and operational excellence.
Medical Devices Directive (MDR)
The company has successfully transitioned to the new MDR (Medical Device Regulation) framework from the former MDD (Medical Devices Directive) certification framework. This transition reflects our commitment to aligning with the latest EU medical device regulations for enhanced safety and performance standards.
93/42/EEC – Medical Devices Directive (MDD)
This European Union directive ensures that HPO TECH hyperbaric chambers meet essential safety and performance requirements for medical devices. Compliance with MDD guarantees that the chambers are suitable for therapeutic use within healthcare settings.
UKCA – UK Conformity Assessed
Applicable to the UK market, this certification confirms that our chambers meet post-Brexit regulatory requirements for medical devices, ensuring compliance with safety, performance, and environmental protection standards.
ASME PVHO – Pressure Vessels for Human Occupancy
This American Society of Mechanical Engineers (ASME) standard ensures that our hyperbaric chambers are designed and built to safely accommodate human occupants under pressurized conditions, reducing risks associated with high-pressure environments.
ASME U-Stamp
An ASME U-stamp is a certification mark from the American Society of Mechanical Engineers (ASME) indicating that an unfired pressure vessel complies with strict safety, design, fabrication, and testing standards under Section VIII, Division 1 of the Boiler and Pressure Vessel Code (BPVC). It signifies authorized manufacturing and rigorous inspection.
PED – Pressure Equipment Directive
An European standard that regulates the design, manufacturing, and testing of pressurized equipment, ensuring the hyperbaric chambers can safely handle the pressures required for hyperbaric therapy.
ISO 13485 – Medical Devices Quality Management System
This certification confirms that HPO TECH adheres to internationally recognized standards for medical device manufacturing, ensuring quality control throughout the product lifecycle.
ISO 45001 – Occupational Health and Safety Management System
Ensures that our chambers are manufactured under a management system that prioritizes employee safety and health in the workplace.
ISO 9001 – Quality Management System
This directive ensures the mechanical safety of hyperbaric chambers, covering aspects such as moving parts, emergency stops, and user interfaces to protect operators and patients from mechanical hazards.
ISO 14001 – Environmental Management System
Confirms that the company follows environmental best practices in its manufacturing processes, reducing ecological impact and ensuring sustainability.
ISO 27001 – Information Security Management System
Ensures that the company protects sensitive patient and operational data through strict information security management protocols.
2001/95/EC – General Product Safety Directive
This European Union directive sets general safety requirements for products placed on the EU market. HPO TECH hyperbaric chambers comply with its provisions, complementing the device-specific CE marking under the Medical Device Regulation (MDR).
Turk Lloydu – Hydrostatic Testing and Conformity Assessment
Turk Lloydu provides certification for pressure testing and structural integrity of hyperbaric chambers, verifying their safety and compliance with international hydrostatic standards.
NFPA – National Fire Protection Association (USA)
Establishes fire safety guidelines for hyperbaric chambers, ensuring compliance with strict fire prevention and suppression standards within medical environments.
ANEP 26 – Ergonomic Military Standards
This ergonomic standard establishes general human engineering design criteria for military systems, subsystems, equipment, and facilities
Medsafe, New Zealand
New Zealand’s medical device regulatory body ensures that HPO TECH chambers meet national healthcare standards for safety and effectiveness.
Thai FDA – Thailand
The Thai FDA ensures our hyperbaric chambers meet strict safety and performance standards before they can be legally sold. Approval signifies regulatory compliance, allowing distribution in Thailand.
FDA – Ghana
The Ghana FDA certification marks a decisive step forward in our mission to support healthcare, wellness, recovery, and human performance across Africa.
Saudi Food and Drug Authority (SFDA)
HPO.TECH hyperbaric chambers are certified as medical devices by the Saudi Food and Drug Authority (SFDA) and hold full marketing authorization in the Kingdom.
UAE – Ministry of Health
HPO.TECH is certified by both the UAE Ministry of Health and Prevention (MOHAP) and the Emirates Drug & Medical Devices Regulation Agency (EDE). This double certification affirms that every HPO.TECH system meets the UAE’s strictest medical and technical standards for safety, quality, and performance.
UAE – Emirates Drug & Medical Devices Regulation Agency (EDE)
HPO.TECH is certified by both the UAE Ministry of Health and Prevention (MOHAP) and the Emirates Drug Establishment (EDE). This dual certification confirms that our hyperbaric systems comply with the UAE’s rigorous regulatory requirements for medical device safety, quality, and clinical performance, enabling their use across hospitals, clinics, and healthcare facilities throughout the Emirates.
