1.1 Is it considered a “medical device” or a “product” to which liability can attach, and if so, under what
The software used within digital health apps can be classified either as medical devices within the meaning of the Legislative Decree no. 46/1997, which has implemented Directive 93/42/EEC, or as simple consumer product to which the regulations on general product safety apply.
In light of Legislative Decree no. 46/1997 medical device means any instrument, device, implant, substance or other product, used alone or in combination, including information software used for correct operation and intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention, control, therapy or mitigation of a disease, diagnosis, control, therapy, mitigation or compensation of an injury or handicap; study, replacement or modification of the anatomy or physiological process.
Basically, the software is classified as a medical device if it has at least one feature involving the use of patient-specific data to support the physician in prescribing or calculating treatment dosage.
Therefore, the decisive factor is whether the software was intended by the manufacturer to be used for one or more medical purposes.
In order to qualify the software as a medical device or not, it is also possible to rely on the indications of the “Manual on borderline and classification in the Community regulatory framework for medical devices.”
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)?
The exclusions from liability for damages caused to patients by the product (i.e., the software) are listed in the Italian Consumer Code. In particular, with reference to liability for product damage, the same is excluded:
- if the manufacturer has not put the product into the market;
- if the defect that caused the damage did not exist when the manufacturer put the product into the market;
- if the producer did not manufacture the product for sale or for any other form of distribution for consideration, nor did they manufacture or distribute it in the exercise of their professional activity;
- if the defect is due to the conformity of the product with an imperative legal provision or a binding measure;
- if the status of scientific and technical knowledge, at the time the manufacturer put the product into service, did not yet allow the product to be considered as defective;
- in the case of the manufacturer or supplier of a component part or raw material, if the defect is entirely due to the design of the product into which the part or raw material has been incorporated or to its conformity with the instructions given by the manufacturer who used it.
It should be noted, however, that although the definition of defective medical device provided in the new Medical Device Regulation (“MDR”) is based on the notion of defective product set forth in Directive 85/374/EEC and the Italian Consumer Code, it is partially different: “defect” in such case is any deficiency in the identity, quality, durability, reliability, safety or performance of a device, including malfunction, errors in use or inadequacy of the information provided by the manufacturer. The reference to the lack of performance of the device is undoubtedly noteworthy since, according to the MDR, “clinical performance” means the ability of a device to achieve the intended use declared by the manufacturer, thus providing a clinical benefit to patients.
The new concept of defective medical device therefore goes beyond the boundaries drawn by the Consumer Code, for which the concept of defect is closely related to the concept of safety (a product is defective when it does not offer the safety that can legitimately be expected, taking into account all the circumstances) and does not correspond to the definition of “defect,” which is identified in an imperfection of the good and may also not lead to a lack of product safety.
As mentioned above, the MDR is not yet applicable, therefore it is arguable that even the definition of “defective device” provided for therein cannot be used in any possible litigation arising from damage caused by devices; it is not excluded, however, that the case law might (de facto) adopt the stricter concept of “defect” of device provided for in the MDR, thus widening the notion of “safety” of the product in order to benefit possible injured parties.