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.
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