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Liability for medical devices II

In previous article of our Life Science & Pharma Practice Group prepared by a colleague dr. Zsófia Sallai, we focused mainly on the vigilance system of the EU and the procedures about to be taken in case of any incident. In this article we would like to summarize the liability itself, focusing on its form, terms of its limitations and the liable person.

Liability for medical devices includes many specific areas – not only liability for damage caused by a defective medical device, but also for wrong or missing notification, non-compliance with legal requirements, any flaws regarding placement on the market, etc. We can summarize, that in most of the CEE states, the largest portion of liability cumulates within the manufacturer, whose liability for safety of medical devices can be described as general e.g. in Latvia, Hungary or Poland. However, in some states, the liability cannot be generalized, since the liable person is always a question of investigation and it cannot be assumed in advance, which is e.g. the case of Slovakia – each of the participants in the process is specifically liable for complying with his own obligations.

In some states, as for example in Czech Republic, the manufacturer is in a specific situation regarding the liability, since he (as well as the national authority supervising the medical devices) is supposed to lead the inquiry to find the liable person in a particular incident. Otherwise however, the manufacturer can be liable as well as any other participant of the process.

It is necessary to keep in mind, that talking about liability for medical devices we shall take into account all three types of liability – penal, administrative and civil. This stands for all CEE. For incompliance with legal requirements for medical devices, for its erroneous placing on market, or failures in other necessary procedures, usually the administrative liability is considered, resulting in a financial sanction for the liable person. The amount of the fines varies – e.g. in Bulgaria, it can rise up to BGN 20,000 (approx. EUR 10,223), in Estonia up to EUR 3,200.

Meanwhile, civil liability arises towards the person aggrieved/injured, if any. The liable person might be obliged to damages. E.g. in Lithuania, rights of the patients are specifically stipulated in the Act on Rights of the Patients and Compensation for Health Damage, and the claims are decided by a supervisory authority.

Considering penal liability, we must distinguish between states with criminal liability of legal persons (e.g. Czech Republic) and those where a legal person can only be administratively liable (e.g. Bulgaria). Dependent on such distinction, directly the respective legal person can be held criminally liable, such as the manufacturer, provider, or others (not excluding the potential criminal liability of a natural person), or the criminal liability shall lie upon the natural persons affected.

Generally, there are no specific crimes covering only the area of medical devices. The respective defective behaviour shall be subordinated under a less specific crime. It is necessary to highlight, that a crime does not have to be committed by a wilful act, but will mostly be committed in the form of negligence. In Belarus for example, crimes such as “Failure to provide medical services by a healthcare professional” or “Violation of sanitary, epidemiological, hygienic requirements and procedures, stipulated by technical regulations causing illness or poisoning of people or death” can be taken as examples of crimes that could be negligently committed in connection with medical devices.

In the vast majority of CEE states, no special provisions of limitation of liability exist for the area of medical devices. The limitation periods therefore proceed from the general civil, administrative of penal provisions. However, in Lithuania, the Act on Health System of Lithuanian Republic stipulates a specific limitation period for the area of healthcare (3 years subjective and 5 years objective).

As a last thought with regard to liability for medical devices, we would like to draw your attention specifically to the problematic of notifications. Breaking the notification obligations generally represents the highest risk leading to liability in the area of medical devices.