Defining and clarifying the organisation's needs is essential for identifying relevant AI systems that can address the challenge. For example, if you want to acquire an AI system that is to be used for one or more medical purposes involving human subjects, it may be classified as a medical device (see phase 2) [18]. It must also be clear who will use the AI system and who or what it will be used on. Similarly, the level of autonomy with which the system will operate must be considered. It must be assessed whether an AI-based solution is both feasible and appropriate. If the problem can be addressed more effectively, simply, or cost-efficiently using a non-AI approach, this should also be mapped and evaluated.
[18] Medical devices are defined in Article 2 (1) of the MDR and include software which, according to the manufacturer, is intended to be used on human beings for, inter alia, the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Kvalifisering av medisinsk utstyr (dmp.no)