Interoperability

Devices meant to work with other devices must be designed so the combination is safe, and the manufacturer has to say which combinations it supports. Interoperability problems often surface as data errors rather than obvious failures.

‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended.

EU MDR, Article 2(26)

‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended;

IVDR, Article 2(19)