Making integration easier: digital pathology display now qualified as in vitro device in Europe and the US
News · Digital pathology displays · 4 min read
We are happy to announce that our MDPC-8127 display for digital pathology is now qualified as an in vitro device in Europe, in addition to its existing IVD registration with the FDA.
What is the in vitro device regulation?
The European regulation on in vitro diagnostic medical devices (IVDR) sets high standards of quality and safety for in vitro diagnostic medical devices to meet common safety concerns associated with these products.
New qualification of the MDPC-8127 as a Class A in vitro device
The MPDC-8127 was originally qualified as a Class IIa medical device in Europe. Following constructive communication with our customers and partners, we have requalified the digital pathology display as a Class A in vitro device. In the United States, the MDPC-8127 has always been an in vitro device with the FDA.
For the MDPC-8127, we successfully implemented the stringent regulatory requirements of the IVDR, which include demonstrating the MDPC-8127’s safety and performance. No hardware or software changes were made – the only change is the registration itself, which is reflected on the product label on the physical monitor.
Why the transition from medical to in vitro device?
At Barco, we keep a close eye on the market and regularly sync with our partners and customers. A frequently recurring question was a requalification of the MDPC-8127 monitor as an in vitro device, which makes it easier to integrate the display into whole slide imaging systems. Digital pathology scanners and viewer software are also in-vitro devices, for example.
After detailed assessment we concluded that the MDPC-8127 is indeed better qualified as an in vitro device instead of a medical device, in line with its intended use and its existing qualification in the USA and Australia.
By taking full responsibility for all the display’s regulatory obligations, we can enable our partners and end users to focus on system-level integration. And the pathologists themselves? They can work with peace of mind, with reliable and robust whole slide imaging systems.
If you have any questions about this transition or about the MDPC-8127 in general, don’t hesitate to reach out to us. Our team will be happy to help you out.
