3 May 2023
Medical Device Regulation (MDR) is an important new initiative launched in 2021 which replaced the previous Medical Device Directive. The new Regulation has stricter requirements for any type of medical device that is available on the European market. This means patients are protected from the consequences of using unsuitable material for medical use and they can have peace of mind that standards are scrutinised. Barco has recently received its EU MDR certificate and is now compliant with new European legislation for medical devices.
Each device is categorised in one of several classes ranging from I to III. The Barco diagnostic displays for radiology, breast imaging, digital pathology and dentistry and certified as Class IIa products.
The MDR also has an impact on non-European medical markets, because many non-European countries take the European legislation as guideline or requirement.As Katrien Cardoen, Healthcare Compliance Director at Barco, explains: “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.”