1.1 Is it considered a “medical device” or a “product” to which liability can attach, and if so, under what regulations?
The classification as a medical device is based on the Swiss Therapeutic Products Act and the Swiss Medical Devices Ordinance. Pure software such as an app or an algorithm could qualify as a medical device. According to the Federal Office of Public Health, an app "is a medical device as soon as it can detect or treat diseases, i.e., if it has a medical purpose for an individual and it does more than store, archive or communicate data. Accordingly, apps that measure fitness data or apps used for statistical analysis of clinical or epidemiological data are not medical devices. Similarly, electronic patient registries and information platforms are not medical devices". The Federal Administrative Court has, for example, qualified an app for monitoring the menstrual cycle as a medical device (BVGer C-669/2016, dated 17 September 2018).
1.2 Is it considered a “product” to which civil liability can attach, and if so, under what regulations?
A medical device within the meaning of the Therapeutic Products Act is not necessarily also a product within the meaning of the Swiss Product Liability Act (“PLA”). While a software-based device purporting to have a medical effect can be qualified as a medical device, it is controversial if it can also be qualified as a product under the PLA. Art. 3 para. 1 lit. b PLA explicitly mentions electricity as the only immaterial good to be treated as a product in the sense of the PLA. The grammatical interpretation of this provision would mean that software would not be covered by the definition of a "product" in the sense of the PLA. However, many voices in the doctrine advocate a contemporary interpretation in line with the purpose of the law and the interpretation of the EU Directive No. 85/374/EEC, which, according to the Federal Supreme Court, is to be consulted as an aid to interpretation (BGE 133 III 81, 83 ff.). Following this progressive interpretation, which we believe is justified, software qualifies as a product. However, there is no case law on this specific question.
Apart from that, civil liability may occur from general contract law. Since software is mostly provided as a service to the end customer, agency law according to art. 394 ff. CO is usually applicable.
1.3 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)?
If the PLA would be applicable on software, the grounds for exclusion of liability are to be found in art. 5 PLA. Accordingly, a manufacturer may exempt itself from liability if he/she proves that:
- he/she did not place the product on the market; or
- he/she can be assumed from the circumstances that the defect that caused the damage did not yet exist when it placed the product on the market; or
- he/she did not manufacture the product for sale or any other form of distribution with an economic purpose, nor did it manufacture or distribute the product in the course of its professional activities; or
- the defect is attributable to the fact that the product complies with mandatory regulations issued by the public authorities.
Since product liability is a causal liability, the grounds for exclusion of liability are not linked to a lack of fault. Rather, they require the absence/presence of one of the above mentioned factors.
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