The healthcare arm of gas equipment company GCE has been awarded a Medical Device Regulation (MDR) certification for its medical VIPR (valves with integrated pressure regulators) products.
Published in 2017 as a replacement for the Medical Device Directive, the MDR framework is a set of rules that govern the safety and performance requirements of medical devices in the European market.
To achieve and withhold compliance, manufacturers must undergo clinical evaluations, risk assessments and post-market surveillance activities to ensure safety of the devices.
“Currently, the MDR certification encompasses a selection of GCE’s premium products, including MediVital, MediVital E, MediVitop and other VIPRs for selected customers, joining the list with the previously approved Medimeter Tube Flower,” stated a GCE spokesperson.
©GCE’s MediVital range.
For devices that are already on the market under the MDD, the application of the MDR was extended in March 2023 to the end of 2027 or 2028 (depending on the medical device classification).
The extension of the MDR aims to reduce disruptions in the availability of medical devices in the European market and to ensure a smooth transition from the previous framework to the new one.
GCE Healthcare’s VIPR valves are designed to combine the duties of both the cylinder valve and pressure regulator.
The technology is designed to provide complete gas control to deliver medical gases either to downstream devices such as ventilator/anaesthesia apparatus, or directly to the patient.
The MediVital range of valves are approved for working pressures of 300 bar with a service life up to 15 years and supplied globally for service in hospitals, ambulances, paramedic emergency kits and respiratory homecare.
According to Grand View Research, the global medical gas equipment market size was valued at $2.34bn in 2022 and has been projected to grow at a CAGR of 7.8% between 2023 and 2030.
The hospital segment dominated the market in 2022 with a revenue share of 28.61%, driven by medical gas equipment sales including cylinders, pressure regulators, flow meters and other devices.
