Barco, global leader in medical visualization and connectivity solutions, has now qualified its MDPC-8127 display for digital pathology as a Class A in vitro device in Europe, in addition to its existing IVD registration with the FDA.

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

The MPDC-8127 was originally qualified as a Class IIa medical device in Europe. Following constructive communication with customers and partners, Barco has 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.

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. By taking full responsibility for all the display’s regulatory obligations, Barco enables its partners and end users to focus on system-level integration.