1.1 Is it considered a “medical device” or a “product” to which liability can attach, and if so, under what regulations?
Software within digital health apps can be considered a medical device provided that it falls under the definition of Act CLIV of 1997 on Healthcare (“Healthcare Act”). The definition of medical device in the Healthcare Act has been amended in line with Regulation (EU) 2017/745 on medical devices (“MDR”) for harmonisation purposes, and Section 3 point h) of the Healthcare Act defines medical device by reference to Article 2 point (1) of the MDR. Pursuant to Article 2 point (1) of the MDR, medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; or
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The detailed rules for medical devices are included in Decree 4/2009. (III. 17.) of the Minister of Health on medical devices and Decree 8/2003. (III. 13.) of the Ministry of Health, Welfare and Family on in vitro diagnostic medical devices, which have also been updated and amended in line with the MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”).
As part of the transition from the previously applicable Medical Device Directive 93/42/EEC (“MDD”) to the MDR, the old MEDDEV documents that applied under the MDD are gradually being replaced by guidance documents of the Medical Device Coordination Group (“MDCG”) established under Article 103 of the MDR. The MDCG issued a Guidance on Qualification and Classification of Software in MDR and IVDR (“ MDSW Guidance”) in 2019 (available here), which defines the criteria for the qualification of software falling within the scope of the new medical devices regulations and provides guidance on the application of classification criteria for software under MDR and IVDR. The MDSW Guidance states that a medical device software is a software that is intended to be used, alone or in combination, for a purpose specified by the above-mentioned definition of Article 2 point (2) of the MDR.
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)?
According to Article 10 (16) of MDR and Article 10 (15) of IVDR, natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law, therfore manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, implement measures to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC (“Product Liability Directive”), without prejudice to more protective measures under national law. Furthermore, pursuant to Article 11 (5) of MDR, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
The Hungarian law, however, does not set out any specific legal regime regarding the liability relating either to the software in digital health apps or to medical devices in general. So, if the software is considered a medical device, liability can attach as it would with any other product. The main applicable rules on contractual, non-contractual liability and product liability as well as the grounds for exempting therefrom can be found in Book 6 of Act V of 2013 on the Civil Code (“Civil Code”).
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