Good news! We’ve received our Medical Device Regulation (MDR) certificate. MD-what? In a nutshell, it means that our full medical product line is now compliant with a new European legislation for medical devices.
How it all started: some background
MDR stands for Medical Device Regulation. It replaces the Medical Device Directive, which was in place since 1993. The MDR is a European law with stricter requirements for any type of medical device that is available on the European market.
It all started in 2005, when a manufacturer of silicone breast implants started to use a self-made formula of silicone. This resulted in leaking implants that remained on the market, and a series of incidents that occurred over more than ten years before authorities started taking actions.
Protecting patients across Europe
The issues with the unsafe breast implants led the European government to rethink their medical device legislation. The new MDR’s goal is to protect patients from the devices that they encounter during their treatment. In short, it increases patient safety and will eventually save people from the consequences of material that is not suitable for medical use.
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.