Protecting patients across Europe
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.
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 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.
What does this mean for our customers?
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.
We take our responsibility towards our customers and their patients
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.”
