Our diagnostic displays for radiology, breast imaging, digital pathology and dentistry are certified as Class IIa products. Our surgical and clinical displays are Class I medical devices.
Risk classification for patient safety
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, as well as QAWeb Enterprise and 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.
What does this mean for our customers?
Our Healthcare Compliance Director Katrien Cardoen explains: “Our products have not changed, but their regulatory process has become stricter. The MDR is all about the protection of patients in Europe. So, if anything, MDR will bring our customers more peace of mind.”
At the time of writing, we appear to be one of the first diagnostic display manufacturers to achieve a Class IIa MDR compliance. Many non-European countries take the European legislation as guideline or requirement, so the MDR could have an impact outside the EU as well. We do not expect it to impact import or export procedures. Our Class IIa products will also be audited every year, for continued peace of mind.