Operating environment

MDCG 2019-16 asks manufacturers to state the minimum IT requirements their device expects from this environment, such as hardware, network and security settings. Hospitals and other users rely on that information to install and run the device securely.

The operating environment for a medical device is defined as any IT/network asset interacting with the medical device that is not supplied by the medical device manufacturer.

MDCG 2019-16 Rev.1, Section 3.6, Minimum IT Requirements