Healthcare: Medical Devices 2023 Comparisons

Medical Devices, In-Vitro Medical Devices, Medical Instruments

In Hungary, the applicable product safety regulatory regime for these types of products is primarily governed by European Union (EU) regulations.

The main regulatory framework for medical devices, including software-based medical devices and medical instruments are the following EU and harmonised Hungarian laws:

• the Medical Device Regulation (EU) 2017/745 (MDR);
• In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR);
• Decree No 4/2009 (III. 17.) of the Minister of Health on medical devices; and
• Decree No 3/2003 (III. 13.) of the Minister of Employment and Labour and of the Minister of Health, Social Affairs and Family on in vitro medical devices.

Personal Protective Equipment

EU Regulation No 2016/425 on Personal Protective Equipment (PPE Regulation) sets forth the essential health and safety requirements for personal protective equipment, including protective clothing, helmets, gloves, masks, and similar protective wearables and equipment. Medical protective equipment, such as surgical face masks or rubber gloves, that fall under the scope of MDR must also comply with the safety criteria stipulated in the MDR.

Cosmetics

Regulation (EC) No 1223/2009 on cosmetic products and Government Decree No 246/2013 (VII. 2.) on cosmetic products, establish the safety and labelling requirements for cosmetics.

Biocides

The requirements for the authorisation, placing on the market, and use of biocidal products and the evaluation and approval processes for active substances and the obligations of manufacturers, importers, and distributors of biocidal products are set forth in Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products and Decree No 18/2008 (XII. 3.) of the Minister of Social and Labour Affairs on requirements and certification of conformity of personal protective equipment.

Food and Nutrition Supplements

The regulation of food, including gene-edited products or GMOs, and nutritional supplements in Hungary is governed by various EU regulations, including Regulation (EC) No 178/2002 on general food law, Regulation (EC) No 1829/2003 on genetically modified food and feed, and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. The most relevant Hungarian legislation which sets forth the regulatory requirements with respect to foods and nutrition supplements are the following:

• Act XLVI of 2008 on the food chain and official controls; and
• Decree No 37/2004 (IV.26.) of the Minister of Health, Social Affairs and Family on food supplements.

In Hungary, the governing safety regulatory regimes for medicinal products are based on and follow EU legislation. The applicable safety regulatory regime for pharmaceuticals, blood products, psychedelics, and cannabidiol is outlined below.

Pharmaceuticals

Directive 2001/83/EC on the Community code relating to medicinal products for human use lays down the guiding rules and goals that EU countries must follow when setting the domestic legal regulation for pharmaceuticals. In the EU, directly applicable rules for the centralised authorisation and quality supervision of medicinal products for human use are laid down in Regulation (EC) No 726/2004.

Act XCV of 2005 on Medicinal Products for Human Use and the Amendment of Other Regulations Related to Medicinal Products (Medicine Act) sets forth the main requirements for clinical trials, authorisation, manufacturing, wholesale activity and pharmacovigilance. In addition to the Medicine Act, Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (Drug Economy Act) outlines the principal provisions concerning the reimbursement, distribution and promotion of pharmaceuticals in Hungary.

Regarding the clinical trials of medicinal products, the applicable legal framework is regulated in Regulation (EU) No 536/2014 on clinical trials of medicinal products for human use (CTR Regulation), which became effective on 31 January 2023.

Blood Products

The legal framework for blood products is defined by EU Directive No 2002/98 on setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components. In Hungary, the applicable regulatory regime is provided for by Act CLIV of 1997 on the Healthcare (Healthcare Act) and Decree No 3/2005 (II. 10.) of the Minister of Health. Furthermore, Government Decree No 439/2015 (XII. 28.) sets forth additional provisions and requirements for the National Blood Supply Service for the management of the national blood supply, especially during import and export activities.

Psychedelics

Act IV of 1965, promulgating the New York Single Convention on Narcotic Drugs, and Decree No 78/2022 (XII. 28.) of the Minister of Internal Affairs on controlled substances, categorise psychedelic drugs. Schedule I drugs, used as pharmaceutical raw materials, are considered highly controlled substances. Pursuant to Decree No 43/2005 (X. 15.) of the Minister of Health on the regulation of prescribing, pharmacy distribution, use, registration, and storage of medicinal products classified as highly controlled substances, highly controlled substances can be used only for medicinal and scientific purposes.

Cannabidiol (CBD) When Used for Medicinal Purposes

Those products that meet the definition of medicinal products and contain cannabis-derived substances, such as cannabidiol (CBD), must comply with the relevant provisions of Directive 2001/83/EC and Regulation (EC) No 726/2004. At present, in Hungary one medicinal product containing CBD as an active ingredient is registered, through a centralised authorisation procedure. This product is for the treatment of patients with epilepsy. If there is a need for an authorised CBD-containing medicinal product, the product can be imported to Hungary after receiving the approval of the National Centre for Public Health and Pharmacy (Nemzeti Népegészségügyi és Gyógyszerészeti Központ or NNGYK).

Medical Apps and Wearables

Pursuant to the definition of medical devices provided by the MDR, any wearable and software intended by the manufacturer to be used, alone or in combination, for human beings for specific medical purposes, such as diagnosing, preventing, monitoring, predicting diseases or disabilities, or investigating the anatomy or physiological or pathological process or state, is deemed to be a medical device. Thus, medical applications and wearables with an intended medical purpose are considered medical devices and fall under the scope of the MDR. If the medical apps provide therapeutical advice for the users (patients), the medical app qualifies as a healthcare service and shall comply with the requirements of pursuing healthcare services. The intended purpose of a medical app or a wearable determines if the product is considered a medical device.

Telemedicine

As per the European Commission Staff working document on the applicability of the existing EU legal framework to telemedicine services dated 2012, EU member states are primarily responsible for the organisation, financing, and delivery of healthcare. Accordingly, developing and providing a regulatory framework remain the responsibility of each member state.

As a result of the COVID-19 pandemic, when institutional care posed a high risk, especially for chronic patients, a detailed regulatory framework of telemedicine was introduced in Hungary. The Hungarian government established the regulatory framework to ensure the ongoing and long-term continuity of telemedicine by Act LVIII of 2020 on transitional provisions and epidemic readiness related to the cessation of the state of emergency.

Stem Cells

Medicinal products containing stem cells, as well as genes and tissues, used for medical purposes are considered advanced therapy medicinal products in the EU. Regulation (EC) No 726/2004 sets forth the applicable rules for advanced therapy medicinal products. Additionally, Directive 2001/83/EC determines additional applicable rules on advanced therapy medicinal products. In Hungary, in addition to the governing EU legislation, the provisions of the Healthcare Act apply, which sets forth, among others, the governing requirements regarding stem cell-related medical research. Decree No 18/1998 (XII. 27.) of the Minister of Health on the Implementation of the Provisions of Act CLIV of 1997 on Healthcare Concerning Organ and Tissue Transplantation and Storage and Certain Pathological Examinations sets forth the applicable rules regarding the collection of cord blood for haematopoietic stem cell transplantation and additional detailed requirements.

The classification of borderline medical and nutritional products requires careful consideration of different factors. The key factor for the classification of the listed borderline products is the claims made by the manufacturer regarding the product’s intended use and mode of action.

If the product serves more than one purpose or function which may fall under several regulatory regimes, a case-by-case assessment is required to determine the appropriate classification. It must be stressed that, under Hungarian law, it is the manufacturer’s responsibility to determine the product’s proper category, in light of the intended use of the product and by considering its characteristics and effects.

For example, if the product is primarily intended to achieve a pharmacological, immunological, or metabolic effect on the human body, it is likely to be classified as a medicinal product. However, if the product is primarily intended for diagnostic or therapeutic purposes, including monitoring or alleviating diseases or medical conditions, it may be classified as a medical device.

With respect to combination products, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a guideline on the classification and quality documentation for medicinal products when used in conjunction with a medical device.

Legal requirements for manufacturing entities in Hungary concerning medical devices, healthcare products and digital healthcare products qualifying as medical devices are governed by a combination of Hungarian and EU laws outlined in 1. Applicable Product Safety Regulatory Regimes.

Requirements on Processes, Quality and Design

Medical devices, healthcare products, and digital healthcare products qualifying as medical devices and marketed in Hungary must comply with the relevant EU regulations, such as the MDR and the IVDR. Manufacturing entities must establish and maintain a comprehensive Quality Management System (QMS) in accordance with the MDR and the IVDR. The QMS covers all aspects and stages of the product life cycle, including design, development, production, distribution and post-market activities.

To ensure compliance with the MDR and the IVDR, the manufacturing sites must warrant that the following requirements are met:

• manufacturing site personnel must be adequately trained and qualified to perform their tasks in a manner that ensures product quality and safety;
• manufacturing entities must use appropriate equipment that is regularly calibrated and maintained to ensure accuracy and reliability;
• manufacturers must have processes in place to control the sourcing, handling, and storage of raw materials and components used in the manufacturing process;
• manufacturers must have robust design and development processes in place to ensure that medical devices are designed to meet their intended purpose and comply with all applicable regulatory requirements and safety standards;
• manufacturers must conduct risk assessments and establish risk management processes to identify and mitigate potential hazards associated with their products; and
• manufacturers must implement systems for traceability to track the movement of products and components throughout the supply chain.

Requirements in Respect of the Entity Responsible for Compliance Requirements Overall

Medical devices are subject to different conformity assessment procedures based on their risk class. The conformity assessment involves evaluation to ensure compliance with the relevant regulations, carried out by those notified bodies which are published by the Commission in the NANDO information system. As part of the conformity assessment, manufacturing processes of the responsible entities must also be certified.

The MDR requires that each manufacturer or their authorised representative designate a person responsible for regulatory compliance (PRRC) internally. The PRRC is responsible for ensuring that the medical devices meet the requirements of the MDR. The PRRC is also responsible for establishing and managing the post-market surveillance system to monitor the performance and safety of the medical devices following their placement on the Hungarian market. The PRRC is liable for reporting incidents, accidents, and other events related to the medical devices to the NNGYK in Hungary, as required by the applicable regulations and may conduct internal audits and inspections at the manufacturing site to verify that all regulatory requirements are being followed.

Post Marketing Requirements

Manufacturers must prepare and maintain technical documentation to demonstrate the conformity of their products with applicable requirements. This documentation should be readily available for the inspection of the competent authorities. The NNGYK has the authority to audit the compliance of the manufacturers’ activities and that of their devices.

Manufacturers must report adverse events or incidents related to their products to the competent authorities as per the applicable reporting guidelines and timelines.

Manufacturers should have procedures in place for initiating product recalls or implementing corrective actions if safety issues or non-compliance of the products are identified.

Also, in accordance with the MDR and the IVDR, manufacturers of medical devices are required to have a Unique Device Identification (UDI) system to enhance traceability and facilitate post-market monitoring.

There is no specific law mandating corporate social responsibility (CSR) activities for companies operating in the territory of Hungary. However, CSR initiatives have gained prominence as businesses recognise the importance of social and environmental responsibility. In Hungary, a number of companies voluntarily adopted CSR practices to demonstrate their commitment to sustainable development, ethical business practices and community engagement.

Hungary is subject to EU environmental regulations and directives. Directive 94/62/EC on the Packaging and Packaging Waste requires member states to set up systems for the return, collection, reuse or recovery (including recycling) of used packaging to meet the EU recycling targets. As a result, Hungary set up an EPR scheme for packaging waste management in 2021, which came into effect in July 2023.

Annex 1 of Government Decree No 80/2023 (III.14.) on Extended Producer Responsibility (EPR Decree) lists the type of products that are covered by EPR obligations. The EPR Decree considers the manufacturer of the circular products as the primary responsible entity for EPR obligations.

Pharmaceutical companies and medical device companies may become subject to EPR obligations as follows:

• by reselling medicines or medical devices imported from abroad with packaging or purchasing packaging from abroad; and
• for packaging removed from the products imported from abroad, if the extended producer responsibility fee for the packaging was not paid in advance.

Efforts are made at the EU level to improve the environmental impact and sustainability factors during the design, manufacturing and distribution phases throughout the product life cycle of medical devices and consumer healthcare products. This includes using eco-friendly materials, reducing waste, and implementing energy-efficient production processes, sustainable packaging and transportation methods to minimise the environmental impact during distribution.

Both at EU and Hungarian levels, advertising and product claims regarding medicinal products, medical devices and other healthcare products are regulated in detail to protect consumers and ensure accurate information is provided to the public. In addition to a strict legal framework, there is an extensive self-regulation activity by market players. In general, pharmaceuticals are subject to much stricter and more detailed requirements than the other product types listed in Section 1.

As a general rule, advertisements of medical devices and healthcare products qualifying as medical devices cannot contain any misleading, false, or deceptive information that could mislead consumers about the product’s characteristics, benefits, or safety. All statements, slogans must be compliant with the instructions for use (PI) in case of medical devices.

Advertisements must not create a false impression of the product’s performance, quality, or safety. The advertising (as a whole) cannot be misleading about the possible uses or risks and cannot contain any statements, promises and claims that are not compliant with the PI, such as “Effects within one hour”.

Prohibition on Certain Use of Claims

Health claims, especially those related to non-authorised indications of medical devices or healthcare products, should not be made without including the indications in the PI of the medical device by the competent regulatory authorities.

Advertisements cannot promote the inappropriate use of the product, such as a different use from the rules set forth in the PI, and advertisements cannot use inappropriate, alarming, or misleading expressions or pictorial representations of changes in the human body. Generalised statements or claims, such as “the most effective” are not allowed.

Substantiation of Claims

All claims and market leadership statements made in advertising must be substantiated by reliable evidence. Manufacturers or advertisers must have scientific data or other objective evidence to support the claims they make about their products. References shall be unambiguously indicated, and the serialisation of references must be unambiguous, verifiable, and continuous.

If the advertisement compares the product with another product, the comparison must be fair, objective, and supported by verifiable data. Comparative statements cannot discredit or harm the reputation of the competitor and cannot result in any unfair advantage derived from the reputation of the competitor (name, merchandise, brand name, etc).

Legislation on Misleading Environmental Claims

There are no specific legislative measures or guidance documents in Hungary that explicitly target unsubstantiated or misleading environmental claims specifically in relation to medical devices and healthcare products. However, it is important to note that environmental claims and advertising in general are subject to broader consumer protection regulations and advertising standards in Hungary.

While there may be no specific legislation addressing environmental claims related to medical devices and consumer healthcare products, these broader consumer protection laws are applicable if environmental claims are found to be unsubstantiated or misleading, especially if the environmental claims are considered market leadership statements.

Regulatory authorities in Hungary, such as the Hungarian Competition Authority (Gazdasági Versenyhivatalor GVH) and the National Consumer Protection Authority (Nemzeti Fogyasztóvédelmi Hatóság or NFH) are responsible for enforcing the above regulations and investigating potential violations.

Regarding medical devices, in vitro diagnostic medical devices and healthcare products qualifying as medical devices, the MDR and the IVDR set forth the requirements for the safety and performance of medical devices before being placed on the market.

Regarding medical devices, pre-market requirements involve the following steps in the EU:

• Classification – Manufacturers must determine the correct classification of their medical device based on its intended use and potential risks to patients. The MDR categorises medical devices into four classes (I, IIa, IIb, and III), with Class III devices representing the highest risk. The IVDR categorises these devices into four classes (A, B, C, and D), with Class D devices representing the highest risk.
• Clinical investigation – Confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and the acceptability of the benefit-risk-ratio shall be based on clinical data providing sufficient clinical evidence. Sufficient clinical evidence may be different based on the product risk class. In the case of high-risk products or new technologies, a clinical investigation shall be conducted to obtain the required clinical data.
• Conformity assessment – Manufacturers must ensure the conformity assessment of the medical devices to demonstrate that they meet the essential requirements set forth in the MDR and the IVDR. The assessment process and the involvement of a notified body in the assessment varies depending on the classification of the device.

Under the MDR and the IVDR, medical devices and in vitro diagnostic medical devices are not subject to an authority marketing authorisation procedure, which is applicable to medicinal products. Nevertheless, to place these devices on the market, manufacturers are required to obtain a CE marking, which indicates that a device conforms with the applicable requirements set forth in the MDR and/or the IVDR. In accordance with the MDR and the IVDR, manufacturers and medical devices manufactured by them must be registered in the European Database of Medical Devices (EUDAMED). In Hungary, in addition to the registration in the EUDAMED database, if a manufacturer or a distributor based in Hungary intends to distribute medical devices or in vitro diagnostic medical devices in Hungary, they must register as a distributor with the local authority, the NNGYK, prior to engaging in the distribution of these devices.

Harmonised EU Regulations

Given that Hungary is part of the EU, manufacturers, and distributors must meet the obligations set forth in the MDR and the IVDR regarding their medical devices. A CE marking in the EU under the MDR or the IVDR certifies that the product was assessed and met the high safety, health, and environmental protection requirements in the EU. In accordance with EU laws, the medical devices certified under the MDR and the IVDR are allowed to be freely distributed in the EU.

With respect to medicinal products, the applicable regulatory regimes outlined in 1. Applicable Product Safety Regulatory Regimes allow manufacturers or marketing authorisation holders (MAHs) to authorise their products in a single marketing authorisation procedure, such as in a centralised, decentralised or mutual recognition procedure. If the marketing authorisation is granted by the European Commission, MAHs are entitled to place their medicinal product on the entire EU market.

In Hungary, as part of the EU customs union, customs duties on imports and exports of goods between EU member states have been eliminated, which is also a considerable factor for foreign companies in their international expansion plans.

Regulatory Regime and Support for Research and Development

Hungary is a popular choice for foreign companies seeking to expand internationally in the area of clinical research, such as clinical trials conducted relating to medical devices, medicinal products and medical treatments. In addition, the tax system is favourable for foreign companies to create a permanent establishment in Hungary as research and development costs may be subject to tax incentives and other benefits. Furthermore, Hungarian authorities are professionally qualified, and the country has a considerable number of highly skilled healthcare professionals. Hungary provides good recruitment potential for clinical trials due to its patient population.

Costs and Pricing

The fact that prices, costs and wages in Hungary are still moderate compared to other EU countries is also a factor that attracts foreign companies seeking to expand internationally. Last but not least, Hungary can offer an affordable, well-trained workforce for foreign companies.

Post-Market Surveillance Obligations

In accordance with Article 83 of the MDR and Article 78 of the IVDR, manufacturers must plan, establish, document, implement, maintain, and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of medical device. This system is an integral part of the manufacturer’s quality management system and includes monitoring real-world use, analysing adverse events, and addressing potential safety concerns. The results and conclusions of the analysis of the post-market surveillance are summarised in the Periodic Safety Update Report.

Record-Keeping Requirements

With respect to medical devices, both the MDR and the IVDR set forth record-keeping obligations. For instance, manufacturers shall archive the related technical documentation, the declaration of conformity, the EU product verification certificate, post-market surveillance data, and vigilance reporting documentation. The relevant expectation and retention (archiving) period can vary depending on the class of the medical device in the case of clinical data.

Corrective Actions

Corrective actions for medical devices and in vitro diagnostic medical devices refer to measures taken by manufacturers or their authorised representatives to address issues or risks associated with their products once they are on the market. Corrective actions can include various steps, including the issuance of safety alerts, implementing product recalls, issuing field safety notices, or making design or labelling changes. Product complaints, adverse events, or post-market surveillance data may trigger the implementation of corrective actions.

Notification to Regulatory Authorities

In case of incidents or serious risks associated with a medical device or healthcare product, manufacturers are required to report these incidents to the competent authorities of the EU member states where the incident occurred. In Hungary, the competent authority for receiving these notifications is the NNGYK. Additionally, distributors operating in Hungary must register every medical device they distribute with the NNGYK.

The NNGYK

As of 1 August 2023, the NNGYK, as the legal successor of the National Institute of Pharmacy and Nutrition, became the main regulatory authority responsible for ensuring compliance with the legislation set forth for:

• medical devices;
• medical instruments;
• personal protective equipment;
• biocides;
• cosmetics;
• nutritional supplements;
• medicinal products;
• cannabidiol; and
• psychedelics.

Also, the NNGYK plays a crucial role in public health surveillance and disease control in Hungary. NNGYK is involved in monitoring and assessing the safety and quality of blood products, as well as providing guidelines and recommendations for their use. The NNGYK is the competent authority to authorise and monitor the operation of healthcare service providers.

National Food Chain Safety Office (NÉBIH)

In Hungary, the National Food Chain Safety Office (Nemzeti Élelmiszerlánc-biztonsági Hivatal or NÉBIH) is responsible for overseeing compliance with food safety regulations.

Regarding NNGYK and NÉBIH authority proceedings, Regional Government Offices have the competence to proceed in several matters.

National Blood Transfusion Service and National Public Health Centre (OVSZ)

The Hungarian National Blood Transfusion Service (Országos Vérellátó Szolgálat or OVSZ) is the national organisation responsible for ensuring the safety, availability, and quality of blood supply and blood products in Hungary. They oversee the collection, testing, processing and distribution of blood and blood components.

Powers of the NNGYK

The NNGYK has various powers and responsibilities in respect of the products outlined in 1. Applicable Product Safety Regulatory Regimes.

• The NNGYK is responsible for the authorisation of medicinal products in Hungary. It also assesses the safety, efficacy, and quality of pharmaceuticals before granting marketing authorisations and monitors the manufacturing, distribution, and marketing practices of pharmaceutical companies to ensure compliance with respective regulations.
• The authority conducts inspections of pharmaceutical manufacturers, wholesalers, and pharmacies to verify adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
• The NNGYK oversees the registration, certification, and supervision of medical devices and medical instruments in Hungary since 2017. The NNGYK may conduct inspections and audits of manufacturers and distributors of medical devices to ensure compliance with regulatory standards.
• The NNGYK has the authority to regulate and monitor the safety and labelling of cosmetic products in Hungary. The authority assesses the safety of cosmetic ingredients and evaluates product labelling and claims. If safety concerns arise or if cosmetics do not meet regulatory requirements, the NNGYK can take actions, including initiating product recalls or bans.
• The NNGYK has oversight of nutritional supplements in Hungary. Within its regulatory powers, the NNGYK assesses the safety, composition, and labelling of these products and monitors the marketing practices and compliance of nutritional supplement manufacturers and distributors. The NNGYK maintains the list of registered food supplements in Hungary.
• The NNGYK is involved in the regulation of CBD products in Hungary. The authority assesses the safety and quality of CBD-based products, such as oils, creams and ointments, and determines their classification as medicinal products or food supplements.

Powers of the NÉBIH

The four main areas in which the NÉBIH has regulatory powers are:

• food safety;
• animal health and welfare;
• plant health; and
• GMOs and biotechnology.

The NÉBIH is responsible for ensuring the safety and quality of food products in Hungary. The NÉBIH conducts official audits and inspections to ensure compliance with food safety and agricultural regulations. The authority collects samples, conducts laboratory analyses, and takes necessary enforcement actions in case of non-compliance. The NÉBIH collaborates with other authorities, such as customs, police and environmental agencies to ensure comprehensive control of the food chain. The NÉBIH monitors and controls food production processes, hygiene practices, labelling, and traceability of food products.

The NÉBIH is also involved in regulating genetically modified organisms (GMOs) and biotechnology in Hungary. The NÉBIH assesses the safety and environmental risks associated with GMOs and oversees their contained use, deliberate release, and placing on the market.

Act C of 2012 on the Criminal Code (Criminal Code) sets forth criminal offences in Hungary, including product safety offences. Summarised below are all product safety offences from the Criminal Code related to the product categories outlined in 1. Applicable Product Safety Regulatory Regimes:

• violation of the rules of experimental research on humans;
• falsification of medicinal products;
• falsification of health care products;
• criminal offences with harmful consumer goods;
• marketing of substandard products; and
• fraudulent attestation of conformity.

All listed offences may be punished by imprisonment under the Criminal Code.

In recent years, there have been judgments published on the Hungarian Judicial Office’s website relating to the crime of falsifying healthcare products. These cases mainly relate to the falsification and marketing of sedatives and potency-enhancing drugs.

In addition, during the COVID-19 pandemic, there was increased marketing of substandard products and falsification of healthcare products. During this period, the National Tax and Customs Administration Office seized many non-qualifying, substandard protective masks, plastic face shields, disposable protective clothing and oxygen generators.

Legal Bases for Product Liability Claims

According to Point 16 of Article 10 of the MDR, natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable EU and national law. The referenced Section of the MDR states that manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability, without prejudice to more protective measures under national law.

Under Hungarian law, product liability claims concerning medical devices, medicinal products, and healthcare products are primarily based on Act V of 2013 on the Civil Code (Civil Code). According to Section 6:550 of the Civil Code, liability for damage caused by defective products lies with the manufacturer of the concerned products.

Pursuant to Section 6:555 of the Civil Code, the following can serve as the general legal basis for product liability claims:

• the product fails to provide a level of safety generally expected with special regard to the purpose of the product;
• the way in which it can be reasonably expected to be used;
• the information provided in connection with the product;
• the date of the sale of the product; and
• the current state of scientific and technological achievements.

A product shall not be considered defective solely on the basis that subsequently a product providing a higher level of safety is placed on the market. The burden of proof of defect lies with the injured party.

The manufacturer shall be relieved of liability if it is able to prove that:

• it did not place the product on the market;
• the product was not produced for retail purposes, or it was not produced or distributed within the framework of regular business activities;
• the product was in perfect condition at the time when it was placed on the market, and the cause of the defect developed subsequently;
• at the time the product was placed on the market, the defect could not have been discovered given the prevailing level of scientific and technological knowledge; or
• the defect in the product was caused by the application of a statutory or regulatory provision.

It must be stressed that, regarding damages resulting from the proper application of a medicinal product, the manufacturer shall not be exempted from product liability by relying on the fact that at the time the product was placed on the market the defect could not have been discovered given the prevailing level of scientific and technological knowledge.

Pursuant to Article 69 of the MDR, Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, guarantee, or other similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk. At the national level, the Medicine Act sets forth the rules related to liability for damages in connection with investigational medicinal products.

Additionally, with respect to medical devices or other healthcare products, general liability rules and product warranty requirements set forth in the Civil Code shall apply.

Impact of the Technological Advancements in Medical Devices to Product Liability Laws

There is no open public consultation or pending legislation that covers the impact of technological advancements on product liability claims.

As medical devices and healthcare products become more complex with technological advancements, the traditional definitions of product defects in product liability laws may need to be reevaluated. In cases where medical devices or consumer healthcare products involve multiple parties, such as manufacturers, software developers, or component suppliers, the allocation of liability can become more complex.

In the future, legislators may also consider soliciting feedback through public consultations, expert panels, and regulatory agencies to gather information on potential gaps in existing laws and the need for updates or new regulations.

According to Section 6:558 of the Civil Code, the injured party may claim their right to compensation within a three-year limitation period. The term of limitation shall commence when the injured party became or can be expected to have become aware of the damage, the defect in the product and the identity of the manufacturer. The manufacturer shall remain subject to liability for a period of 10 years effective from the date of placing the given product on the market.

Pursuant to Article 7 of Regulation (EU) No 1215/2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (Brussel I), a person domiciled in a member state may be sued in another member state in matters relating to tort, delict or quasi-delict, in the courts at the place where the harmful event occurred or may occur.

In Hungary, Act CXXX of 2016 on the Code of Civil Procedure (Civil Procedure Code) governs which court has the authority to hear and decide on a particular legal dispute. In accordance with the general jurisdiction rules set forth in Section 25 of the Civil Procedure Code, the court in whose area of competence the defendant’s home is located shall have jurisdiction in all actions that are not delegated under the exclusive jurisdiction of another court.

Additionally, pursuant to Section 28 of the Civil Procedure Code, in the absence of exclusive jurisdiction, the plaintiff shall have the option to bring an action for damages on the grounds of non-contractual liability (ie, product liability) before the court of jurisdiction for the geographical location where the harmful event or the damage has occurred, instead of applying the general jurisdiction rules. Pursuant to Section 28 of the Civil Procedure Code, for the enforcement of a claim arising from a contractual relationship (ie, medical device purchase agreements) jurisdiction lies with the court located where the transaction was concluded or where the service was performed.

Under the Civil Procedure Code, if a product liability claim is brought before a court, it is the general rule that the competence of the court is determined based on the amount in dispute. If the amount in dispute does not exceed HUF30,000,000 (approximately EUR75,000), instead of the general courts, the district courts have competence. A duty to initiate the civil procedure must be paid by the initiating party (claimant or plaintiff) at a rate of six percent (6%) of the amount in dispute or not less than HUF15,000 (approximately EUR35) and not more than HUF1,500,000 (approximately EUR3,800).

Under the Civil Procedure Code, the unsuccessful party must bear the legal costs of the successful party. Parties may be entitled to certain types of cost allowances to facilitate the enforcement of their rights in court proceedings, and may be eligible to cost exemption, duty exemption, or exemption from the fee of legal representation.

As a general rule, decisions made by administrative bodies may be subject to judicial review under Section 114 of Act I of 2017 on the Code of Administrative Litigation. Therefore, the regulatory decisions of NNGYK or NÉBIH may be subject to judicial review in Hungary.

Pursuant to Section 2:52 of the Civil Code, any person whose rights relating to personality have been violated shall be entitled to restitution for any non-material violation suffered. To be entitled to restitution, apart from the infringement, no other harm needs to be proven. Restitution as non-material compensation may be awarded in addition to compensation resulting from product liability claims.

Regarding medical devices, the so-called PIP (Poly Implant Prothese) breast implant cases were some of the most notable product-related contentious matters in Hungary. The liability of the manufacturer was established by a court judgment. The scandal led to the manufacturer company’s bankruptcy and in 2021, the liability of the German company issuing the safety certificate was declared.

The Civil Procedure Code sets forth the applicable rules of action for the following collective enforcement of claims:

• actions in the public interest; and
• class actions.

Actions in the Public Interest

Actions in the public interest can be brought before the courts by persons outlined in specific legal regulations, such as the prosecutor, the competent minister, economic and professional chambers or representative organisations, or certain associations, including industry and patient associations. The person entitled to do so may bring an action in the public interest in respect of the following:

• consumer protection;
• environmental protection;
• nature conservation;
• animal protection; and
• violation of the requirement of equal treatment.

In respect of healthcare, medical devices, and healthcare-related products, no specific legal regulation enables the initiation of actions in the public interest. Bringing actions in the public interest is limited to consumer protection matters.

Class Actions

Under the Civil Procedure Code, class actions may be initiated and conducted before Hungarian courts with the following conditions:

• at least ten plaintiffs are concerned;
• the plaintiffs intend to enforce one or several rights of the same cause for all of them (so-called representative right);
• the facts underlying the representative right are substantially identical for all plaintiffs; and
• the court approved the formation of the class.

Class actions may only be brought before courts in the following cases:

• claims arising from consumer contracts;
• labour disputes; and
• claims or damage claims arising directly from health damage caused by unforeseeable environmental burdens resulting from human actions or omissions.

In addition to Hungarian law, regarding the enforcement of the collective interest of consumers, Directive (EU) No 2020/1828 on representative actions for the protection of the collective interests of consumers outlines the regulatory framework for EU member states in this regard.

Hungary has no well-established judicial practice of collective enforcement of claims, especially regarding civil procedures based on class actions.

According to Act CLV of 1997 on Consumer Protection (Consumer Protection Act), arbitration boards operated by the regional chambers of industry and commerce shall have competence in the settlement of consumer disputes outside of courts. With respect to those product categories listed in 1. Applicable Product Safety Regulatory Regimes that qualify as consumer goods, consumers may attempt to reach an agreement with manufacturers or distributors for the settlement of their claims and disputes. A precondition for opening arbitration board proceedings is that the consumer attempts to first settle the case directly with the manufacturer or the distributor. Pursuant to Act LIII of 1994 on Judicial Enforcement, the binding decision of the arbitration board is an enforceable instrument based on which the consumer can initiate enforcement in the event of non-compliance.

Additionally, and in accordance with Section 168 of the Civil Procedure Code, court proceedings are initiated by the parties, and the parties may apply with the court vested with competence and jurisdiction to be summoned for the purpose of reaching a negotiated settlement even if a mediation procedure did not take place beforehand. If the settlement is in line with the relevant legislation, the court shall approve the agreement of the parties as an enforceable instrument.

Given that the offences listed in 4.1 Product Safety Offences are public offences, it is up to the office of prosecution to decide whether to prosecute the offence in question. As filing of a complaint does not automatically lead to criminal prosecution, it is not common to use criminal proceedings to exert pressure in civil litigations.

In connection with the links between product safety compliance and product liability claims, with respect to medicinal products, pursuant to the Civil Code, even if at the time the product was placed on the market the defect could not have been discovered given the prevailing scientific and technological knowledge, the manufacturer shall not be relieved of product liability.

Pursuant to the Healthcare Act and Medicine Act, sponsors are relieved from paying restitution if death, disability or severe health impairment occurs in a clinical trial of a medicine or clinical investigation of a medical device in consequence of the specifications issued by the authorising authority. In this case, the competent authority shall be liable to pay restitution for damages.

One of the most important policy developments in the environmental sustainability field in the EU that affects the operation of medical devices and pharmaceutical companies is the introduction of the EPR system. The main purpose of the EPR scheme is to create a circular economy in the EU and products, raw materials and resources should retain their value for as long as possible, and the waste generated should be recycled as raw materials where possible.

To comply with Directive 94/62/EC on packaging and packaging waste, Hungary set up an EPR scheme for packaging in 2021. MOHU MOL Waste Management Zrt (MOHU) won the tender for the waste management concession of the Hungarian State, meaning that from 1 July 2023, MOHU is responsible for carrying out the integrated waste management services in Hungary.

Economic operators that generate waste falling within the scope of integrated waste management services carried out by MOHU, for the purpose of entering into a contract with MOHU as the concession company, had to register on MOHU’s platform between 1 March 2023 and 30 April 2023.

Manufacturers must pay a financial contribution to MOHU to carry out their activities, known as an extended producer responsibility fee. The obligation to pay the extended producer responsibility fee arises when the manufacturer first places the circular product on the market.

New Healthcare Authority

As of 1 August 2023, the former authority responsible for medical devices, medicinal products and food supplements in Hungary was merged into the National Centre for Public Health. Upon the merger, a single complex healthcare authority, the NNGYK, was established in Hungary, which might affect the current processes and organisation of the authority.

MDR and IVDR Transitional Period

With respect to medical devices, Regulation (EU) No 2023/607 amending the MDR and the IVDR, extended the transition period of the MDR – ie, the date until medical devices certified under Directives 93/42/EEC (MDD Directive) and 90/385/EEC (AIMD Directive) may be placed on the market, and eliminated the sell-off period of the MDR and the IVDR. The Hungarian regulation reflects the above extended transitional period.

New EU Pharmaceutical Strategy

On 26 April 2023, the European Commission published a legislative proposal (the Pharmaceutical Proposal) including proposals for a new EU directive and a new regulation to revise the European pharmaceutical legislation. The Pharmaceutical Proposal is slated to achieve more accessible, effective, and affordable medicinal products by creating a Single Market for medicinal products and to offer an innovation-friendly framework for research in the EU. The Pharmaceutical Proposal is still in the preparatory phase in the European Parliament.

Local Pharmaceutical Updates

In the aftermath of the COVID-19 pandemic, with respect to medicinal products the focus has shifted to the regulation of safety stocks to address shortages in the supply of medicines. The Hungarian Government intends to reform the regulation of pharmacies to ensure that product supply is constant and safe in the whole territory of Hungary.

In Hungary, no specific AI regulation has been introduced yet. In September 2020, the Ministry of Innovation and Technology of Hungary introduced a National Artificial Intelligence Strategy for 2020-2030. In this strategy, the Hungarian Government presented its aim to achieve data-driven healthcare by:

• making available the existing health data through an up-to-date and AI-supported infrastructure;
• developing and introducing AI-supported medical decision-making and medical devices;
• facilitating the development of medical AI applications; and
• improving the quality of health administration and management using AI tools.

The National Strategy also outlines the aim of establishing the ethical and regulatory framework to achieve the objectives set forth therein.

In April 2021, the European Commission announced its legislative proposal of the harmonised rules on artificial intelligence (AI Act Proposal) in the EU. The AI Act Proposal aims to establish rules and requirements for the development, deployment, and use of AI systems within the EU to ensure their safe and ethical use. Under the AI Act Proposal, AI systems related to medical devices are considered high-risk AI systems as they can negatively affect safety or fundamental rights. According to the AI Act Proposal, all high-risk AI systems will be assessed before being put on the market and throughout their life cycle. The AI Act Proposal is currently awaiting the position of the EU Parliament in the first reading.

Regarding the AI Act Proposal, various concerns were already raised, such as being an overly stringent regulation and disadvantaging the competitiveness of companies operating in the EU. Several studies as well as guidance have been published on this subject to contribute to the use of AI systems in the healthcare industry until the AI Act Proposal enters into force. For example, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) published its guidance on artificial intelligence in EU medical device legislation in 2020, summarising its recommendations. In Hungary, no local guidance has been published with respect to AI used in the healthcare industry.

With regard to the relevant provisions of the MDR and the IVDR, AI-based developments can primarily be interpreted in the context of software medical devices. In Hungary, AI systems are mainly presented as diagnostic tools, but the development and use of AI-based medical devices are in their initial phases. The number of new initiatives is steadily rising, and includes AI-supported medical apps intended to conduct quick dermatological examinations to identify various types of skin diseases, such as cancer, infections and autoimmune diseases. AI-based technologies designed for in-vitro diagnostic medical devices – eg, software designed to recognise urine sediment particles in microscopic images – are also being developed.