A PDMS is a software based system usually containing information such as patient identification, vital intensive care parameters and other documented clinical observations. These PDMS are not qualified as medical devices.
“Modules that are intended to provide additional information that contributes to diagnosis, therapy and follow-up (e.g. generate alarms)
are qualified as medical devices.”
Another term for Patient Data Management System is Clinical Information System (CIS).
(MEDDEV 2.1/6, July 2016)