Barco, global leader in medical visualization technology, has received its EU Medical Device Regulation (MDR) certificate. Our full medical product line is now compliant with the new European legislation for medical devices. The MDR was installed to guarantee the safety of medical devices for patients.
MDR stands for Medical Device Regulation. It replaces the previous Medical Device Directive, which was in place since 1993. In contrast to the Directive, the Regulation is a European law with stricter requirements for any type of medical device that is available on the European market. Its goal is to protect patients by implementing strict requirements for the devices that are used throughout their treatment. In this way, the law increases patient safety and will eventually save people from the consequences of material that is not suitable for medical use.
Depending on the potential risks associated with the devices, devices must be categorized in one of several classes, ranging from I to III. Our diagnostic displays for radiology, breast imaging, digital pathology and dentistry together with our medical software (QAWeb Enterprise and suite of Intuitive Workflow Tools) are certified as Class IIa products, because of their purpose for diagnostic use. Our surgical and clinical displays are Class I medical devices.
Katrien Cardoen, Healthcare Compliance Director at Barco, says: “Our products have not changed, but their regulatory process has become stricter. The MDR is all about the protection of patients in Europe, and that is at the heart of our mission. So, if anything, MDR will bring our customers more peace of mind. We took the MDR certification process very seriously.”
The MDR also has an impact on non-European medical markets, because many non-European countries take the European legislation as guideline or requirement. We do not expect the MDR to impact import or export procedures.
It is vital that products are certified correctly and in time. “We enjoyed an excellent and productive collaboration with our notified body TÜV SÜD Product Service GmbH,” continues Katrien Cardoen. “They will continue auditing our processes and products on a yearly basis. It is an investment that we are happy to make to keep contributing to a healthier world.”
Barco is a global company with headquarters in Kortrijk (Belgium). Our visualization and collaboration technology helps professionals accelerate innovation in the healthcare and enterprise and entertainment markets. We count over 3,000 visioneers, whose passion for technology is captured in over 500 unique patents.
Barco is a listed company (Euronext: BAR; Reuters: BARBt.BR; Bloomberg: BAR BB) and realized sales of 1,058 million euro in 2022.
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