Barco has received its EU Medical Device Regulation (MDR) certificate. Its full medical product line is now compliant with the new European legislation for medical devices.
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.
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. Barco does not expect the MDR to impact import or export procedures.