Note: Exact text provided by Health Canada.
For the purposes of this document, “middleware” is defined as follows:
“middleware” means a piece of software that connects two or more software applications so that they can exchange data. This includes software systems that facilitate the interaction of disparate components through a set of commonly defined protocols. The purpose is to limit the number of interfaces required for interoperability by allowing all components to interact with the Middleware using a common interface.
As defined above middleware would not fit the definition of a medical device.