1.1 Is it considered a “medical device” or a “product” to which liability can attach, and if so, under what regulations?
Under Rules on Medical Devices (Pravilnik o medicinskih pripomočkih, Official Gazette of RS, no. 37/10 and 66/12) a product is classified as a medical device if it, in relation to its properties and main purpose of operation, meets the definition of a medical device.
The software component may be classified as medical device under Medical Devices Act (“ZMedPri”, Zakon o medicinskih pripomočkih, Official Gazette of RS, no. 98/09) if it is intended to be used on human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process; or
- control of conception,
and does not achieve its principal function in or on the human body by way of pharmacological, immunological or metabolic means (although it may be assisted in its function by such means).
When in doubt whether a product needs to be classified as a medical device, an application for the classification may be submitted to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (“JAZMP”).
1.2 If your response to Q1.1 is yes, please state whether there are any exclusions/exemptions applicable with regard to liability, and/or whether those are applicable only under certain circumstances (e.g., for in-hospital use)?
This question should be assessed on case by case basis.