The dynamic development of the computer games market has led to a significant change in the monetization models used by game producers and publishers. The traditional sales model, based on a one-time purchase of a product by the consumer, has been largely replaced by solutions based on long-term user engagement and generating revenue through micropayments (microtransactions). Mechanisms known as loot boxes, consisting in the paid purchase of virtual packages with random content.

Although initially perceived as a means of enhancing gameplay, this mechanism is currently the subject of intense legal, economic, and social debate. It is increasingly being pointed out that the design of loot boxes utilizes psychological mechanisms similar to those that have been present in traditional gambling games for many years. The random nature of the reward, the uncertainty of the outcome, the “near miss” effect, the limited availability of certain items, and the use of dynamic animations intended to enhance the user’s emotional engagement all contribute to the blurring of the line between entertainment and gambling mechanisms.

Additional controversy stems from the fact that the vast majority of modern games using loot boxes are also aimed at minors. Unlike traditional gambling games, participation in these mechanisms does not require a specific age or meeting specific formal requirements. In practice, this means that random monetization mechanisms are also used by children and adolescents, who, due to their stage of psychological development, are particularly susceptible to the influence of behavioral design techniques and so-called dark patterns).

In recent years, the issue of loot boxes has ceased to be analyzed solely through the prism of gambling law. Regulations concerning consumer protection, digital services, and child safety in the online environment are gaining increasing importance. Discussions at the European Union level indicate that the future legal framework may be based not only on classic definitions of games of chance but also on instruments to combat manipulative practices and ensure a high level of protection for consumers using digital services.

At the national level, the problem remains equally relevant. Polish lawmakers have not yet decided to introduce a separate definition of loot boxes into the Gambling Act of 19 November 2009. This does not mean, however, that these mechanisms remain entirely outside the scope of existing regulations. In practice, administrative bodies assess each specific business model on a case-by-case basis, analyzing whether its design meets the statutory definition of gambling. At the same time, the development of the secondary market for trading in virtual items, particularly so-called skin gambling , is creating new interpretative challenges that the legislature did not anticipate when enacting the current regulations.

The changes introduced by the PEGI rating system in 2026 provided an additional impetus for reassessing the current regulations. The revised rules for classifying games with paid random mechanisms confirm the growing awareness of the risks associated with the use of loot boxes, especially for underage users. Although the PEGI rating is not a source of generally applicable law, its practical importance for the European market remains significant and may influence both the distribution of games and the future direction of legislative changes.

The purpose of this article is to analyze the current legal status of loot boxes under Polish and European Union law, taking into account recent regulatory changes, the practices of administrative bodies, and the experiences of selected European countries. Particular attention will be paid to whether the current regulations effectively protect consumers from mechanisms based on randomness and whether the current regulatory model meets the challenges of the modern digital economy.

The essence of loot boxes and their functioning models

The concept of a lootbox has not yet been defined in either Polish or European Union law. However, in the literature and by public institutions, it is generally accepted that a lootbox is a mechanism whereby the user obtains, for a fee or free of charge, a virtual package containing items whose contents remain unknown until opened. A characteristic element of this solution is randomness – the user has no influence on the item they receive, and the probability of obtaining individual rewards is determined by the game developer or platform operator.

At the definitional level, however, it should be emphasized that the term “lootbox” encompasses a wide variety of business models, the legal assessment of which cannot be uniform. Public debate often equates all mechanisms based on randomness with gambling, while from a legal perspective, individual solutions differ in both their economic structure and the degree of risk to the consumer. It is precisely this diversity that means that assessing the compliance of lootboxes with applicable regulations requires an analysis of the specific operational model, not just the presence of a random element.

The most classic model occurs in games where lootbox content is limited solely to cosmetic items, such as skins , animations, character outfits, or visual effects. These items do not affect gameplay or increase the player’s chances of success. They are intended solely for aesthetic purposes, allowing the user to personalize the appearance of their character or equipment. Such solutions were long considered relatively safe from a consumer protection perspective, but the development of secondary markets for trading virtual items has significantly changed their economic significance.

A good example is the Counter-Strike series, where weapon skins initially served only a visual purpose. Over time, however, a robust secondary market developed around these items, allowing them to be sold for real money. Consequently, the value of some virtual items began to reach several thousand, or even several dozen thousand, and in exceptional cases, several hundred thousand euros. In practice, this means that a randomly acquired item can have a tangible financial value, even though the game developer itself does not officially allow for its sale. The existence of an external market is one of the main arguments raised in the discussion on the classification of such mechanisms as potentially akin to gambling.

Loot boxes used in sports games, such as EA SPORTS FC Ultimate Team, are of a different nature. In this model, users purchase virtual packs containing player cards, coaches, or other team items. Unlike skins in games like Counter-Strike, acquired items directly impact gameplay. Acquiring rare players can increase a team’s competitiveness and improve player performance. Although the developer publishes information regarding the probability of receiving rewards in a given category, the user still doesn’t know the contents of a specific pack at the time of purchase, and the decision to purchase is based on a random mechanism.

Yet another model is found in so-called gacha games, extremely popular, especially in Asian markets and in the mobile gaming segment. This mechanism is based on randomization of characters, equipment, or other items necessary for further progression in the game. A characteristic feature of gacha systems is their close connection to long-term user monetization. Players are encouraged to repeatedly make micropayments to obtain exceptionally rare characters or items, the probability of obtaining which can be extremely low. The literature indicates that these solutions most fully utilize the mechanisms of behavioral economics and the psychology of addiction.

However, the most controversial are third-party platforms that enable the trading of virtual items and participation in games of chance that use items from video games as a form of currency. These services operate independently of game developers, leveraging the existing market for skins or other digital goods to organize mechanisms reminiscent of classic casino games. Users deposit funds or use their virtual items to participate in lotteries, roulette, duels, or other games based on chance. Unlike traditional loot boxes offered by game producers, the participant’s goal is not only to obtain a specific item but often to achieve a tangible economic benefit resulting from the possibility of reselling it.

From a legal perspective, the differences between the presented models are crucial. Not every mechanism employing an element of randomness automatically leads to its classification as gambling. Factors that should be assessed include, first and foremost, the potential for financial gain, the existence of a secondary market, the method of financing participation, the possibility of withdrawing funds, and the actual impact of randomness on achieving a specific outcome. In practice, this means a case-by-case analysis of the specific business model, rather than adopting a uniform classification for all types of loot boxes .

This approach is also reflected in the practice of many European countries. Both administrative bodies and courts are increasingly moving away from abstract assessments of the lootbox mechanism itself, focusing instead on analyzing their actual operation and impact on consumer interests. Consequently, the current legal debate no longer revolves around the question of whether lootboxes as a category should be considered gambling, but rather which monetization models justify their inclusion in a specific regulatory regime.

Loot boxes and the definition of gambling in Polish law

Assessing the compliance of lootbox mechanisms with Polish law requires, above all, an analysis of the provisions of the Gambling Act of 19 November 2009. Although the legislature has not yet decided to introduce a separate definition of lootboxes, this does not mean that these mechanisms remain outside the scope of applicable regulations. On the contrary, in practice, their legal classification depends on whether the specific operating model meets the criteria for one of the games specified in the Act.

The basic premise of the Gambling Act is to subject activities in which the outcome depends on chance to a specific regime, and the participant gains the opportunity to obtain a specific financial or material benefit. The Act does not use the term “lootbox” because it was enacted at a time when modern computer game monetization models were practically nonexistent. This necessitates a functional interpretation, taking into account the economic nature of the mechanism in question, not just its name or the technical solutions adopted by the game developer.

A key element of most loot boxes is undoubtedly randomness. The user making the purchase neither knows the contents of the package nor has the ability to influence the outcome of the drawing. However, the mere presence of a random element is not sufficient to classify a given mechanism as gambling. In practice, the nature of the prize received by the participant and the ability to assign it a real economic value are equally important.

This is where a fundamental difference between classic loot boxes offered by game developers and the mechanisms used by third-party platforms for trading virtual items becomes apparent. If the item obtained through a draw has a purely aesthetic function and cannot be legally exchanged for cash or used outside of the game environment, the arguments for classifying such a mechanism as gambling are significantly weaker. The situation is different when the item is de facto a property that can be freely traded on the secondary market, yielding a real financial benefit.

In practice, the greatest controversy surrounds so-called skin gambling. In this model, users use items obtained in-game as a means of participating in subsequent games of chance organized by third parties. Skins, which were originally purely cosmetic, are beginning to function as a kind of digital currency with measurable economic value. This mechanism leads to a situation in which participants risk losing items of real-world value in exchange for the opportunity to win an even more valuable reward. This structure bears a much greater resemblance to classic gambling games than the traditional micropayment systems used by game developers.

At the same time, caution should be exercised before drawing too far-reaching conclusions. The mere existence of a secondary market does not automatically mean that every loot box should be classified as gambling. From a legal perspective, a case-by-case analysis of the entire business model is necessary, including, among other things, the method of acquiring virtual items, the possibility of their resale, the role of the game producer, the scope of control over the trade in digital assets, and the actual economic significance of the rewards. Consequently, two mechanisms utilizing an identical element of randomness may be subject to entirely different legal assessments.

This position is also reflected in the practice of Polish administrative bodies. To date, there has been no established practice of automatically classifying all loot boxes as gambling. Authorities focus instead on analyzing specific business models and assessing whether they meet the requirements of applicable regulations. This approach reflects the nature of the Gambling Act, which uses functional definitions, leaving authorities considerable scope for assessing individual factual circumstances.

In this context, the practice of entering certain online platforms into the Register of Domains Used to Offer Gambling Games in Contravention of the Act has become particularly significant. However, such an entry does not mean that all platforms utilizing the element of randomness conduct illegal activities. Each decision is preceded by an assessment of the specific operational model of the given service. Consequently, it cannot be assumed that the lootbox mechanism itself has been deemed illegal in Poland. It is not the abstract technical structure that is being assessed, but rather its practical application.

Under current law, it seems more appropriate to ask not whether loot boxes per se constitute gambling, but which of their numerous operating models demonstrate characteristics that justify the application of the provisions of the Gambling Act. This approach avoids oversimplification and better reflects the reality of the digital market, where solutions with widely varying levels of risk to consumers coexist.

At the same time, it should be noted that even if a given mechanism does not meet the criteria for gambling within the meaning of the Act, this does not mean there is a lack of legal oversight. Modern regulations increasingly refer to consumer protection instruments, counteracting manipulative practices, and ensuring the safety of children using digital services. Therefore, analysis of loot boxes cannot be limited solely to gambling law. Regulations regarding consumer protection, digital services, and designing interfaces in accordance with fair trading principles are gaining increasing importance, and in many cases, they may prove to be a more effective tool for protecting users than traditional gambling law instruments.

Loot boxes as a challenge to consumer protection law and the regulation of digital services

Although the debate surrounding loot boxes has for many years focused primarily on gambling law, a shift in regulatory direction is now becoming increasingly apparent, both at the national and European Union levels. Contemporary challenges related to random mechanisms in computer games concern not only the classification of specific models as gambling, but also the compliance of the practices employed with the principles of consumer protection, the protection of minors, and the fair design of digital services.

This change is primarily due to the development of the digital economy. The mechanisms used by game producers are increasingly based not on traditional product sales, but on long-term user engagement and gradual increase in spending through appropriately designed psychological solutions. This phenomenon is referred to in the literature as behavioral monetization, or monetization that leverages knowledge from cognitive psychology and behavioral economics. The goal of such mechanisms is not simply to facilitate a purchase, but to create an environment that encourages users to make subsequent purchasing decisions impulsively or emotionally.

Of particular importance in this regard are so-called dark patterns, referred to in Polish literature as manipulative or deceptive design patterns. These design solutions exploit the workings of human perception and decision-making processes to induce behaviors that are beneficial to the entrepreneur, but not necessarily aligned with the consumer’s true interests. In the case of loot boxes, these can take a variety of forms – from counters counting down the time until the end of a promotion, through messages about the limited availability of specific rewards, to elaborate animations that enhance the emotional experience of opening the packages.

These mechanisms are not coincidental. Psychological research indicates that a reward system based on a variable ratio reinforcement schedule is one of the most effective ways to maintain long-term user engagement. This same mechanism has been used for many years in classic gambling games, where the unpredictability of rewards maintains a high level of motivation for subsequent attempts. In the case of loot boxes, this mechanism is transferred to the computer gaming environment and combined with an attractive audiovisual setting and the ability to immediately make another purchase.

From the perspective of consumer protection law, a crucial question is whether the use of such solutions could lead to a violation of traders’ obligations arising from provisions on fair market practices. It should be noted that contemporary EU regulations increasingly place greater emphasis not only on the content of information provided to consumers, but also on the design of digital interfaces. Therefore, the subject of assessment is increasingly not the product or service itself, but rather the architecture of the purchasing process and the impact of the interface on the user’s freedom of decision-making.

Underage users are particularly important here. Both the European Commission and the European Parliament have repeatedly stated that children using digital services require a higher level of protection than the average consumer. This stems from their limited ability to assess economic risk and their greater susceptibility to persuasive techniques used by businesses. In practice, this means that solutions acceptable to adult users may be deemed disproportionate or unfair if they are primarily targeted at children and adolescents.

The importance of this issue has increased following the entry into force of Regulation (EU) 2022/2065 on the Digital Single Market (Digital Services Act – DSA). Although this act does not explicitly regulate lootbox mechanisms, it establishes a number of obligations regarding the design of digital services and the protection of users from practices that may negatively impact their decision-making autonomy. In particular, the DSA emphasizes the need to ensure a high level of protection for minors and limit the use of solutions that exploit the vulnerabilities of specific user groups. This trend indicates that future assessments of the legality of lootboxes will increasingly be conducted not only through the lens of gambling law but also taking into account consumer protection standards applicable in the digital environment.

In parallel, the European Commission is working on a legislative package known as Digital Fairness, which aims to adapt EU consumer protection regulations to the realities of the digital economy. Issues under review include manipulative design patterns, interface design that exploits user vulnerability, and mechanisms that exert excessive psychological pressure during purchasing decisions. Although the legislative work has not yet been completed, the direction of the proposed changes clearly indicates that future regulations may also cover monetization mechanisms used in video games.

The European Parliament also highlighted the need to enhance the protection of minors in its resolution of 26 November 2025 on the protection of children online. The document indicated that mechanisms such as loot boxes, in-game currencies, and other systems based on chance should be subject to special scrutiny from the perspective of protecting children from addictive and manipulative digital practices. While the resolution is non-binding, it provides an important political signal indicating the direction of future legislative action at the European Union level.

A separate but crucial element of the modern user protection system is the PEGI age rating. Starting in 2026, this system will adopt a more stringent approach to games featuring paid random mechanisms, recognizing them as solutions requiring a higher age rating. While the PEGI rating is not a source of law and does not in itself determine the legality of specific monetization models, it reflects a growing consensus on the need to provide greater protection for minors from mechanisms that utilize randomness and behavioral design techniques.

The above circumstances lead to the conclusion that the future of loot box regulation will likely be shaped primarily by regulations concerning consumer protection and digital services, rather than solely by traditional gambling law instruments. While the Gambling Act focuses on the qualification of specific business models, contemporary EU regulations increasingly assess the design of digital services and their impact on the autonomy of user decisions. Consequently, assessing the legality of loot boxes in the future will require comprehensive consideration of both gambling law and regulations concerning consumer protection, digital services, and children’s rights.

Approach of selected European countries to regulating loot boxes – a comparative analysis

The lack of a uniform definition of loot boxes in European Union law has led individual member states to develop different models for regulating this phenomenon. These differences concern not only the legal classification of random-based mechanisms but, above all, the assessment of the risks loot boxes pose to consumers, especially minors. As a result, the European Union currently boasts both countries adopting a very restrictive approach and jurisdictions that prefer to analyze individual business models rather than create separate statutory regulations.

Belgium has taken the most stringent stance for many years. The Belgian Gaming Commission has determined that certain lootbox mechanisms meet the criteria for gambling if the participant pays a fee, the outcome depends on chance, and the reward represents a specific economic value. Consequently, some game producers have decided to remove paid lootboxes from the Belgian market or significantly limit their functionality. This solution was primarily preventative in nature and aimed at limiting children and adolescents’ exposure to mechanisms that utilize randomness as a monetization tool .

The Dutch experience was different. For many years, the Dutch supervisory authority took a similar stance to the Belgian one, deeming certain lootbox models to be in violation of gambling regulations. The dispute concerned one of the most popular monetization models used by Electronic Arts became the subject of years of administrative and court proceedings. However, the final rulings demonstrated that the classification of loot boxes cannot be based solely on the presence of an element of randomness, but requires consideration of the overall economic structure of the game, the method of trading virtual goods, and the actual potential for financial gain for the user. The Dutch experience thus highlighted the difficulties associated with applying traditional definitions of gambling law to new business models operating in the digital economy.

At the opposite extreme is the approach adopted in Poland. To date, Polish lawmakers have not decided to create separate regulations regarding loot boxes or introduce a statutory definition. This means that the assessment of individual models is based on applicable gambling regulations and an analysis of the specific factual circumstances. This approach provides administrative bodies with significant interpretative flexibility, but also limits predictability for businesses operating in the digital market.

The practice of Polish authorities indicates that a functional assessment of the specific business model is crucial. In the case of platforms enabling the use of virtual items as a means of participating in games of chance, authorities may apply the instruments provided for in the Gambling Act, including entry into the Register of Domains Used to Offer Gambling Games Contrary to the Act. However, this does not automatically mean that all loot boxes used in computer games are illegal. The Polish model is therefore based on an analysis of the economic impact of a given solution, not on an abstract assessment of the randomness mechanism itself.

An analysis of the solutions adopted in individual countries leads to the conclusion that what is becoming increasingly important is not simply classifying loot boxes as gambling, but rather protecting consumers from the psychological mechanisms that lead to excessive spending or compulsive behavior. Therefore, many countries are beginning to perceive the loot box problem as an issue that goes beyond traditional gambling law and requires the use of instruments appropriate to consumer law and digital market regulation.

This approach also aligns with actions undertaken at the European Union level. The European Commission and the European Parliament increasingly point out that the fragmentation of national regulatory models can lead to uneven levels of user protection in the digital single market. The global nature of game producers’ operations means that businesses operate simultaneously in multiple markets, adapting their business models to the most stringent requirements in force in individual countries. In practice, this means that future legal solutions will likely aim for greater harmonization of consumer protection standards at the EU level.

However, this doesn’t mean a complete ban on loot boxes is necessary. A much more likely approach would be to introduce requirements regarding the transparency of random mechanisms, the publication of actual reward probabilities, more effective age verification of users, and restrictions on the use of solutions that exploit the vulnerability of children and adolescents to persuasive techniques. Such a regulatory model would preserve the possibility of using micropayments as a legal method of financing computer games while simultaneously strengthening consumer protection.

From the perspective of Polish law, the experiences of other European countries have significant interpretative significance. They demonstrate that mechanisms operating at the intersection of gambling and digital services cannot be assessed solely through the lens of classic legal constructs developed for traditional casinos or lotteries. The development of the digital economy requires a more comprehensive approach, taking into account both the economic significance of virtual goods and the impact of interface design on consumer decisions. Consequently, the future model for regulating loot boxes will likely be based on a combination of instruments from gambling law, consumer protection law, and regulations governing digital services, rather than the exclusive application of one of these legal regimes.

Conclusions de lege lata and postulates de lege ferenda

The analysis leads to the conclusion that current Polish law does not allow for a uniform legal classification of all lootbox mechanisms. Despite the growing number of voices calling for the recognition of lootboxes as a form of gambling, the current legal status does not provide a basis for automatically subjecting this entire product category to the provisions of the Gambling Act of 19 November 2009. Each assessment requires consideration of the actual operation of the specific business model, the nature of the prize, the potential for further turnover, and the economic impact of user participation in the random mechanism.

This doesn’t mean, however, that the current regulations remain entirely insufficient. With respect to some models operating on the market – particularly platforms that use virtual items as a means of participating in games of chance or enabling their exchange for cash – current regulations may be applicable. The practice of administrative bodies to date demonstrates that the Gambling Act remains an instrument that helps counteract the riskiest forms of activity, especially when virtual goods begin to function as an equivalent of money or property.

At the same time, it’s important to note that the vast majority of modern loot boxes don’t pose a classic gambling law problem. Their primary purpose isn’t to organize games of chance in the traditional sense, but to create a monetization model that leverages psychological mechanisms that increase user propensity to make subsequent purchases. For this reason, the current regulatory debate is increasingly shifting from gambling law toward consumer protection law and the regulation of digital services.

It seems that this is precisely the direction that Polish lawmakers should also adopt. Attempting to classify all loot boxes as gambling would oversimplify the extremely diverse digital market. A much more rational solution seems to be creating separate regulatory obligations for mechanisms that utilize randomness, without the need for automatic application of the entire gambling law regime.

First and foremost, it seems reasonable to introduce full transparency into random mechanisms. Before making a purchase, users should be able to familiarize themselves with the actual probability of winning individual prizes, how the randomization algorithm works, and whether this probability remains constant for all participants. Such solutions already exist in some computer games, but currently they are primarily driven by voluntary decisions by businesses or requirements in specific foreign markets.

The second direction of change should be to strengthen the protection of underage users. In light of current psychological knowledge and the positions of EU institutions, there is little doubt that children are particularly susceptible to the influence of mechanisms based on a variable reward system. Therefore, it seems reasonable to consider limiting the ability of people under a certain age to purchase paid loot boxes or introducing mandatory parental control mechanisms to effectively manage minors’ expenses.

Regardless of the above, legislators should consider introducing more detailed regulations regarding third-party platforms enabling the trading of virtual items. It is this market segment that currently raises the greatest concerns from the perspective of consumer protection and compliance with the Gambling Act. In particular, situations in which items obtained in-game become a means of participation in subsequent games of chance or can be directly converted into cash require analysis. In such cases, the line between a digital service and gambling activity becomes significantly blurred, justifying the application of more restrictive oversight measures.

Obligations regarding marketing activities should also be a crucial element of future regulations. In practice, loot boxes are primarily promoted through influencers and online creators, whose audiences often include minors. While advertising collaborations in and of themselves cannot be deemed unacceptable, situations in which marketing messages exclusively emphasize the possibility of winning exceptionally valuable prizes, disregarding the actual probability of winning them, or employing techniques that could create unreasonable expectations among recipients regarding potential benefits, require special consideration. In this regard, both consumer protection regulations and regulations regarding the integrity of advertising messages may apply.

The issues presented demonstrate that the issue of loot boxes is not limited to gambling law. In fact, it exemplifies a much broader phenomenon involving the use of advanced digital design techniques to influence users’ economic decisions. Technological advancements increasingly render traditional private and public law frameworks inadequate for assessing new business models based on user behavior analysis and interface design that maximizes consumer engagement and spending.

Consequently, the future of loot box regulation will likely depend less on further expansion of the definition of gambling than on the development of European consumer protection standards in the digital environment. Regulations on the transparency of digital services, countering manipulative design patterns, and ensuring a high level of protection for children using the internet are becoming increasingly important . These instruments may become the primary tool for mitigating the risks associated with loot box operations in the coming years.

It should therefore be assumed that effective regulation of this phenomenon requires a multifaceted approach, combining instruments of gambling law, consumer protection law, and digital market regulation. Only such a comprehensive solution will achieve the right balance between the freedom of game producers to conduct business and the need to ensure a high level of protection for users, particularly children and adolescents, who remain most vulnerable to the negative effects of random-based mechanisms.

Artykuł Lootboxes in Computer Games – Between Gambling Law and Consumer Protection. Regulatory Analysis Against the Background of Polish and European Union Law. pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Biostimulants in aesthetic medicine – current regulatory challenges for manufacturers, distributors and clinics

The aesthetic medicine market is currently one of the fastest-growing healthcare segments in Europe. Particularly dynamic growth is observed in so-called tissue biostimulants, preparations used to stimulate the body’s natural regenerative processes. While traditional fillers dominated just a few years ago, today both manufacturers and physicians are increasingly turning to preparations containing poly-L-lactic acid (PLLA), calcium hydroxyapatite, polynucleotides, and collagen preparations, whose mechanism of action is based on the stimulation of tissue regeneration processes rather than solely on mechanical effects.

The growing popularity of these products, however, raises a number of legal questions. These concern not only their qualification as medical devices, but primarily the manner of communicating their properties and permissible forms of promotion. In practice, manufacturers, importers, distributors, and aesthetic medicine clinics increasingly face the dilemma of drawing the line between providing reliable product information and advertising, which is subject to stringent legal restrictions.

This issue has become particularly important following the entry into force of the Act of April 7, 2022, on Medical Devices and the issuance of the Regulation of the Minister of Health on the Advertising of Medical Devices. Polish legislators have decided to introduce some of the most detailed regulations regarding the advertising of medical devices in Europe. These restrictions directly impact the activities of manufacturers, distributors, importers, healthcare providers, and marketing agencies serving the aesthetic medicine industry.

At the same time, it’s important to remember that advertising medical devices does not operate in isolation from other legal regulations. Businesses must consider not only the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and the Medical Devices Act, but also regulations on consumer protection, combating unfair market practices, combating unfair competition, personal data protection, and sometimes regulations governing the practice of medical professions and healthcare activities. Consequently, a single marketing campaign may be subject to simultaneous assessment under several different legal regimes.

Particular difficulties arise with products used exclusively by individuals with appropriate professional qualifications. In practice, most biostimulants are administered via injection by a physician or other qualified medical professional. This raises the question of whether products intended exclusively for professional use can be advertised at all, and if not, how can businesses legally present information about their offerings on websites, social media, or at industry conferences.

The purpose of this study is to present practical aspects of applying regulations regarding the advertising of medical devices, using tissue biostimulants as an example. Particular attention will be paid to the boundary between advertising and information, the obligations of manufacturers and distributors, the most common marketing errors, and compliance solutions that can reduce the risk of violating applicable regulations.

Biostimulants – why do they raise so much legal controversy?

From a legal perspective, biostimulants constitute one of the most interesting categories of medical devices. Their specificity lies in the fact that, although formally subject to regulations specific to medical devices, their method of use, risk profile, and patient perception often resemble medicinal products more than traditional medical devices.

In market practice, patients often fail to recognize the difference between a medicinal product and a biostimulant. Both types of products are administered in a doctor’s office, require medical qualifications, involve intervention in the body, and may cause adverse reactions. Therefore, for the average consumer, the difference between a medicinal product and a medical device remains almost invisible.

From the perspective of EU law, however, what matters most is not the method of administration or the site of use, but the mechanism by which the principal intended action is achieved. The MDR is based on a fundamental distinction between medicinal products and medical devices. If the principal action is achieved by pharmacological, immunological, or metabolic means, the product will generally be classified as a medicinal product. However, if the mechanism of action is based on other properties – for example, physical or mechanical – the product may be classified as a medical device, even if its use leads to long-term biological effects.

This very boundary has been the subject of numerous interpretational disputes for years. In the case of biostimulants, the preparation does not replace natural processes occurring in the body nor does it produce a therapeutic effect through a pharmacological mechanism. Its purpose is to create conditions enabling the activation of natural regenerative processes, such as stimulating fibroblasts to produce collagen or rebuilding the extracellular matrix. It is this mechanism that causes most currently available biostimulants to be classified as medical devices.

This does not mean, however, that all products marketed as “biostimulants” automatically fall into the same regulatory category. Legal classification is determined by a case-by-case analysis of the specific product, its intended use, and the mechanism of action specified by the manufacturer. In practice, there are also products that, despite similar aesthetic applications, may be subject to different legal regimes, including regulations concerning medicinal products, cosmetics, and medical devices.

This is fundamental for subsequent marketing communications. Already at the product qualification stage, the manufacturer should consider the target audience, the information that can be conveyed to recipients, and the advertising restrictions that will apply. Mistakes made at this stage often result in the need to redesign the entire marketing strategy after the product has been launched.

Can biostimulants be advertised? Limitations under the Medical Devices Act and the MDR Regulation

One of the most frequently asked questions by manufacturers, importers, and healthcare providers is whether biostimulants can be advertised to a broad audience. The answer to this question is ambiguous and requires consideration of both the provisions of the EU MDR Regulation, the Polish Medical Devices Act, and implementing regulations governing advertising.

In practice, a certain pattern can be observed. Many entrepreneurs equate the fact that a product has been legally introduced to the market with the ability to freely promote it. However, this assumption is incorrect. Approval of a medical device for marketing does not automatically mean that the manufacturer or distributor can use any marketing tools. On the contrary, the more specialized the product and the greater the risk associated with its use, the greater the restrictions on its communication.

In the case of biostimulants, it is particularly important that the vast majority of these products are intended for use only by individuals with appropriate professional qualifications. Treatments using them require medical qualification, maintaining appropriate aseptic conditions, and injections performed in accordance with medical knowledge. Therefore, the recipient of the product is not the patient, but a medical professional who then uses the product while providing healthcare services or aesthetic medicine treatments.

This circumstance is of fundamental importance from the perspective of advertising law.

Advertising of medical devices is not advertising of consumer products.

The Medical Devices Act adopts different assumptions than the regulations governing the advertising of ordinary consumer goods. The legislator’s goal was not to create freedom in marketing activities, but to ensure that decisions regarding the use of medical devices are made primarily based on medical knowledge, not advertising messages.

For this reason, the legislator decided to introduce numerous restrictions on both the content of advertising and its target audience. In practice, this means that, already at the design stage of a marketing campaign, entrepreneurs should answer three fundamental questions:

• who is the actual user of the product,
• to whom the message is addressed,
• whether the information provided is of a promotional nature or purely informational.

Only a combined analysis of these elements allows us to assess the compliance of the planned communication with applicable regulations.

The intended use of the product is crucial.

In practice, there’s a common misconception that advertising opportunities are determined solely by how a product is sold. This isn’t the correct approach.

The manufacturer’s intended use of the product and the user group specified in the technical documentation and instructions for use are of much greater importance. If the manufacturer has specified that the product should only be used by professionals, this also influences the assessment of the admissibility of directing marketing messages to individuals without medical qualifications.

This is precisely the situation with most biostimulants. These products are intended for procedures requiring appropriate professional training, knowledge of anatomy, aseptic techniques, and the ability to recognize contraindications. From a regulatory perspective, it would be difficult to justify extensive advertising campaigns aimed at the general public when the product itself cannot be used independently by the average consumer.

This doesn’t mean, however, that businesses cannot provide any information regarding such products. On the contrary, the law permits the provision of information about medical devices, but the line between information and advertising requires individual assessment.

Advertising and information – why is the distinction so important?

In practice, the vast majority of disputes concerning medical device advertising do not focus on obvious promotional campaigns. Much more often, the problem arises with materials that businesses define as “informational,” while from the perspective of regulatory authorities, they may be considered advertising.

Importantly, neither the MDR nor the Medical Devices Act provide a legal definition of medical device advertising. However, the lack of a statutory definition does not imply any freedom of interpretation. Case law and doctrine assume that the nature of a message is primarily determined by its actual purpose, not the name given to it by the trader.

If the primary purpose of the message is to increase interest in the product, build a positive image of the product or encourage its purchase or use, there is a high probability that the message will be classified as advertising, regardless of whether it contains a direct call to purchase.

In practice, this means that even seemingly neutral materials may be considered advertising if they are prepared in a way that highlights only the advantages of the product, ignores its limitations or uses characteristic marketing techniques.

Is the manufacturer’s website itself an advertisement?

This is one of the most frequently asked questions in the practice of law firms advising manufacturers of medical devices.

There is no single universal answer to this question.

The mere presence of product information on a website does not constitute advertising. A website can function as a product catalog, a database of technical documentation, or a platform for communicating with medical professionals. However, if the product’s presentation goes beyond providing objective information and begins to utilize typical marketing mechanisms, the risk of such communication being classified as advertising significantly increases.

For example, posting instructions for use, declarations of conformity, technical data, or information on how to use a product on a website will generally be informative. However, a situation in which the same website includes slogans such as “revolutionary rejuvenation method,” “the most effective biostimulator available on the market,” “instant lifting effect,” or “spectacular results guaranteed” should be assessed differently. In such cases, the message goes beyond neutral information and begins to serve a promotional purpose.

Therefore, designing websites for medical device manufacturers requires close collaboration between marketing departments and legal and regulatory affairs departments . In practice, even seemingly minor changes in product presentation can result in a different legal classification for the entire message.

The boundary between advertising and information – practical problems of producers and aesthetic medicine clinics

While the distinction between advertising and information seems intuitive, in practice it is one of the most problematic issues related to the functioning of the medical device market. This stems primarily from the fact that contemporary marketing communication rarely takes the form of classic television or print advertising. Businesses much more frequently utilize websites, social media, newsletters, podcasts, webinars , expert blogs, and educational materials. Each of these forms can—depending on how it is prepared—be considered both neutral information and advertising.

In practice, there is no single element that automatically determines the classification of a given message. Supervisory authorities and courts analyze all the circumstances, taking into account the content of the message, its form, presentation, audience, and the actual purpose of the publication. This means that even a message containing only truthful information may be considered advertising if its primary purpose is to encourage the purchase or use of a product.

For this reason, businesses should move away from the simple question: “Are we allowed to publish this information?” and instead ask themselves: “How will the average recipient perceive this message?” It is the recipient’s perspective, not the business’s intention, that will in many cases determine the legality of the message.

Website – an entrepreneur’s business card or an advertising tool?

The first place where doubts arise is almost always the manufacturer’s, distributor’s, or clinic’s website. For many businesses, it is their primary channel of communication with the market, yet it is also one of the most frequently scrutinized elements during inspections conducted by regulatory authorities.

The mere presence of information about a medical device on a website is not prohibited. Businesses have the right to present information about the products offered, their properties, methods of use, technical documentation, and instructions for use. However, problems arise when the presentation method goes beyond providing objective information.

A good example is comparing two descriptions of the same product.

The first one could be as follows:

“A preparation intended for the reconstruction of tissue volume in accordance with the instructions for use. The product is intended for use by qualified medical professionals.”

This description is for informational purposes only. It is limited to presenting the product’s intended use and user group.

The following message should be assessed differently:

“The most innovative biostimulator on the market. It instantly rejuvenates the skin and provides a spectacular lifting effect after just one treatment.”

Although both messages refer to the same product, the second employs typical marketing tactics. It uses evaluative terms (“the most innovative,” “spectacular effect”), promises of effectiveness, and suggests a competitive advantage. This type of message is difficult to consider as neutral technical information.

In practice, this means that entrepreneurs should analyze not only the content of the information, but also the way it is expressed. Often, it is individual marketing terms that determine the overall nature of the message.

Newsletters and mailings to customers

Another tool increasingly used by manufacturers and distributors is newsletters and emails directed to customers. Again, not every message can be considered advertising.

If a newsletter contains information about changes in regulations, new regulatory requirements, announcements from supervisory authorities, or changes to product instructions, it will generally serve an informative purpose. However, messages whose primary purpose is to increase sales of a specific product should be assessed differently.

For example, a message titled “Changes to MDR requirements for technical documentation” would be educational in nature. An email with the slogan “Discover the most effective biostimulant available on the market – order today” would undoubtedly serve an advertising function.

This does not, of course, prohibit commercial communication. However, entrepreneurs should remember that such communication is subject to all restrictions applicable to advertising medical devices.

Webinars and training – education or product promotion?

The significant increase in the popularity of webinars organized by medical device manufacturers has also led to this form of communication starting to attract the attention of supervisory authorities.

Organizing training for doctors and other medical professionals is nothing unusual. On the contrary, in many cases, proper user training is an essential element in ensuring the safe use of a device.

The problem arises, however, when a webinar described as a “scientific training” actually focuses almost exclusively on promoting one product, highlighting its advantages while omitting limitations, contraindications, and alternative methods of treatment.

In practice, it is worth adopting the principle that the more educational the material is, the greater the emphasis should be on presenting objective medical knowledge, and not only information beneficial to the manufacturer.

Scientific conferences

Similar problems apply to industry conferences. Sponsorship of scientific events by medical device manufacturers is common practice and raises no objections in itself. However, risks arise when the scientific component is subordinated to marketing objectives.

In practice, particular caution should be exercised when presenting research results for a specific product. Results should be presented honestly, taking into account methodological limitations and the full clinical context. Selectively presenting only favorable data may be viewed as misleading.

LinkedIn – professional communication can also be advertising

Many content creators assume that since LinkedIn is primarily a professional platform, the content published there is strictly business-related. However, this assumption is far-fetched.

If a LinkedIn entry is limited to information about participation in a conference, obtaining a certificate, a scientific publication or organizational changes in the company, it is generally difficult to attribute an advertising nature to it.

However, if a publication contains incentives to use a specific product, comparisons with competitive products, promises of specific clinical effects or highlights the advantages of a product in order to increase sales, it may be considered advertising, regardless of the fact that it was published on a professional website.

LinkedIn is increasingly being used as a marketing platform for the healthcare market. Therefore, communications conducted via this platform should also be subject to the company’s internal compliance procedures.

Social media – the biggest challenge for the biostimulant market

Social media has completely transformed the way patients make decisions. Just a dozen or so years ago, the primary source of information was a doctor’s consultation and manufacturer-provided materials. Today, many patients primarily seek information on Instagram, TikTok, Facebook, and YouTube, guided by the opinions of influencers , physicians with educational profiles, and other users’ testimonials.

For entrepreneurs, this represents a huge marketing opportunity, but also significant regulatory risk. Traditional regulations regarding medical device advertising were designed with press, radio, and television advertising in mind. Modern online communication is much more dynamic and often combines elements of education, personal branding, and product promotion. As a result, assessing the legality of a specific message requires a case-by-case analysis of its actual purpose and context.

Instagram – where does education end and advertising begin?

Instagram remains the most important communication channel used by aesthetic medicine clinics and physicians performing biostimulant treatments. This platform relies primarily on visual communication, which inherently has a stronger impact on audiences than traditional product descriptions.

From a legal perspective, however, it cannot be assumed that every post about a procedure constitutes advertising. Physicians have the right to conduct educational activities, explain the mechanisms of individual procedures, discuss indications and contraindications, and comment on scientific publications. Such activities contribute to increasing patient awareness and should not, in and of themselves, be equated with advertising.

The line is crossed when communication begins to focus on promoting a specific medical device or building its commercial appeal. This applies particularly to publications containing marketing slogans, incentives for procedures, information about price promotions, comparisons with competing products, or emphasizing the exceptional effectiveness of a specific product without providing the full medical context.

In practice, it is worth adopting the rule that the more a post resembles advertising material prepared by a marketing agency, the greater the risk of it being classified as an advertisement for a medical device.

TikTok – short form does not exempt from responsibility

Just a few years ago, few medical device manufacturers considered TikTok a business communication tool. Today, the situation is completely different. More and more clinics are publishing short videos demonstrating treatment procedures, patient reactions, and the aesthetic effects achieved after using specific products.

The specific nature of this platform, however, means that the message is necessarily simplified. A video lasting several dozen seconds rarely allows for the presentation of contraindications, possible side effects, or limitations of the product’s use. As a result, there is an increased risk of creating a one-sided image of the product, highlighting only its benefits.

From a compliance perspective , businesses should therefore exercise particular caution when preparing materials published on platforms based on short audiovisual forms. Merely shortening the message does not exempt them from ensuring its compliance with regulations on advertising medical devices.

Influencer Marketing – New Regulatory Risk

influencers remains one of the most dynamically developing areas of marketing. This phenomenon has also impacted the aesthetic medicine market. Increasingly, individuals with significant social media followings are publishing treatment reports, presenting their recovery processes, and describing their own experiences using specific products.

From a legal perspective, such collaboration requires special caution. Even if the influencer doesn’t mention a specific product, the way the treatment is presented can lead to increased interest in a specific technology or manufacturer. If the publication is created as part of a commercial collaboration, additional obligations arise under regulations regarding labeling advertising content and consumer protection.

In practice, the producer should remember that responsibility for the legality of the message is not always limited solely to the influencer. Depending on the cooperation model, the entrepreneur initiating the campaign may also be responsible for the manner in which marketing communications are conducted.

Doctor as a product ambassador

The use of physicians’ authority to promote medical products remains a particularly sensitive issue. Public trust in medical professionals means their statements have a much greater impact than traditional advertising messages.

This doesn’t mean, however, that doctors cannot publicly comment on the technologies they use. On the contrary, sharing medical knowledge, clinical experience, and research results is a crucial element in the development of medical science and practice. The problem arises only when a doctor’s statement ceases to be expert-based and begins to serve a marketing function.

The risk increases especially when a physician appears in manufacturer-produced materials, uses promotional language, or explicitly encourages consumers to choose a specific product. In such cases, the regulatory authority may determine that the use of the medical profession’s authority serves to increase the product’s commercial appeal, which requires assessment from the perspective of regulations governing the advertising of medical devices.

Before – after photos – an effective marketing tool or a source of risk?

One of the most distinctive elements of communication in aesthetic medicine is photographs depicting the patient’s appearance before and after the procedure. From a marketing perspective, this is an extremely effective tool for influencing potential clients. However, from a legal perspective, its use raises a number of concerns.

Firstly, such materials often lead the recipient to believe that the treatment will provide a guaranteed result. However, the results of medical procedures depend on numerous individual factors, such as the patient’s health, age, biological predispositions, and adherence to post-treatment recommendations . Presenting single, spectacular results can lead to unrealistic expectations.

Secondly, publishing patient photos requires compliance with regulations on personal data protection and the protection of personal rights. Consent to perform a procedure does not constitute consent to the dissemination of the image. The provider should obtain separate, informed, and voluntary consent covering the publication of photographs in specific communication channels.

Third, it’s important to remember that even properly obtained patient consent doesn’t eliminate the risk of a publication being considered an advertisement for a medical device. If a photo is used to promote a specific product or increase interest in a specific procedure, the entire message should be assessed in light of advertising regulations.

In practice, this means that the use of ” before – after ” photography requires simultaneous analysis from the perspective of medical device law, personal data protection, civil law, and consumer protection regulations. Failure to consider even one of these aspects can lead to significant legal risk.

Misleading advertising – why can a truthful message also violate the law?

One of the most common mistakes made by businesses operating in the medical device market is the belief that because all information contained in an advertisement is truthful, the message is automatically legal. However, this assumption is far-fetched and is not supported by either the EU MDR or national regulations regarding medical device advertising.

Assessing the legality of advertising is not limited to verifying the veracity of individual claims. Equally important are the manner in which they are presented, the context of the overall message, and the potential impact on the recipient’s decisions. Advertising can be misleading not only by providing false information, but also by selectively presenting facts, omitting important limitations, or emphasizing only the positive aspects of a product’s use.

This is why Article 7 of the MDR should be considered one of the key regulations governing the marketing communications of medical device manufacturers. This provision prohibits the use of texts, names, trademarks, images, symbols, or other markings that could mislead the user or patient regarding the intended purpose, safety, or performance of the device. This prohibition applies not only to labels and instructions for use but also to advertising materials and other forms of market communication.

In practice, this means that an entrepreneur should analyze each message not only in terms of compliance with the product’s technical documentation, but also from the perspective of how the average recipient might interpret the information presented.

Not only falsehood, but also silence

One of the most frequently underestimated aspects of advertising is the responsibility for omitting information that is important to the recipient. Businesses typically focus on avoiding false claims, much less on analyzing the consequences of omitting specific information.

Imagine an advertisement for a biostimulator in which the manufacturer presents excellent aesthetic results achieved after the treatment. All photographs are authentic, and the description of the effects reflects the actual experiences of selected patients. At the same time, the advertisement contains no information about the need for medical qualification, possible contraindications, the risk of side effects, or the body’s varied response to treatment.

Formally, none of the claims presented are false. Nevertheless, the recipient may be misled into thinking that achieving the presented effect is typical, predictable, and practically guaranteed. Consequently, the message may be considered misleading because it creates unrealistic expectations regarding the product’s performance.

A similar risk arises when using terms such as “safe,” “non-invasive,” “natural,” or “side-effect-free.” Even if a product has a high safety profile, using such phrases can imply an absence of risk, which is difficult to reconcile with clinical reality.

Can we use the terms “best”, “most effective” or “revolutionary”?

Marketing language often relies on the use of evaluative terms. Advertisements feature phrases such as “market leader,” “the most innovative product,” “the best rejuvenation technology,” or “a breakthrough in aesthetic medicine.” In the consumer goods sector, this type of communication is common. However, when it comes to medical devices, much greater caution is required.

First, an entrepreneur should have objective evidence to support any comparative or evaluative claim. Second, even the existence of scientific research does not always justify the use of terms suggesting absolute superiority over all competing solutions. In medical practice, the effectiveness of therapy depends on many factors, including the patient’s qualifications, the physician’s experience, and individual biological conditions.

From a compliance perspective, a much safer solution is to use a description based on clinical trial results and technical parameters of the product, instead of using general marketing slogans.

Practice of supervisory authorities – the growing importance of digital communication

Recent years have seen a significant increase in supervisory authorities’ interest in online communications. While previously, oversight activities focused primarily on traditional advertising materials, they now also analyze websites, social media profiles, newsletters, videos published on streaming platforms , and collaborations with influencers.

This trend is consistent with a broader trend observed at the EU level, where increasing emphasis is being placed on countering manipulative marketing practices and ensuring a high level of protection for consumers using healthcare services. Consequently, businesses should assume that online communications are subject to the same scrutiny as traditional forms of advertising.

The Polish Office of Competition and Consumer Protection and consumer protection – the second pillar of responsibility

Although the primary legislation regulating the advertising of medical devices remains the Medical Devices Act, businesses cannot limit their analysis solely to this legal regime. Consumer protection regulations also apply, in particular the Act on Combating Unfair Market Practices and the Act on Competition and Consumer Protection.

From the perspective of the President of the Office of Competition and Consumer Protection (UOKiK), the impact of a message on the average consumer is of particular importance. If a communication exploits emotions, raises unjustified expectations, or suggests characteristics that the recipient is unable to independently verify, it may be considered a practice that violates the collective interests of consumers.

In practice, this means that a single marketing campaign may be assessed simultaneously by different authorities under different legal frameworks. Manufacturers should therefore design their marketing activities to ensure compliance not only with medical device regulations but also with consumer protection and fair competition regulations.

Compliance instead of reaction after inspection

Experience in recent years shows that a significant number of violations are not the result of deliberate actions by businesses, but rather a lack of appropriate internal procedures. Marketing materials are often prepared by external advertising agencies that are intimately familiar with the mechanisms of selling consumer products but lack experience in the regulated sector.

compliance systems that encompass the entire marketing communications process is becoming increasingly important . Every piece of content – whether it’s an Instagram post, a product brochure, a webinar , or a YouTube video – should be reviewed not only by the marketing department but also by those responsible for regulatory and legal matters.

This approach allows for the identification of risks before the material is published, reducing the likelihood of initiating administrative proceedings, disputes with supervisory authorities and negative image consequences.

The most common mistakes of manufacturers, importers, distributors and clinics – what to avoid in practice?

Recent experience shows that most violations of regulations regarding medical device advertising do not result from deliberate disregard for applicable regulations. Quite the opposite – entrepreneurs operating in the aesthetic medicine market typically strive to conduct their business in compliance with the law, but they encounter difficulties resulting from ambiguous regulations and the dynamic development of modern communication channels. Marketing of medical products is increasingly conducted via social media, educational platforms, and industry events, whereas existing regulations were primarily designed with traditional forms of advertising in mind.

In practice, however, there are several recurring mistakes that occur regardless of the size of the company and which should be taken into account when designing a marketing strategy.

Mistake No. 1 – Equating commercial information with neutral information

One of the most common misconceptions is that material doesn’t constitute advertising solely because a business owner has designated it as “information.” This approach is unsupported by applicable law.

The nature of a message is assessed based on its actual function, not the name given by the author. If the material highlights the benefits of a specific product, builds its market appeal, or is intended to encourage the recipient to choose a specific product, there is a high probability that it will be classified as an advertisement, even if it does not contain a classic call to purchase.

An example would be an article published on the manufacturer’s website titled “Modern Skin Regeneration Possibilities.” If the majority of the text is devoted to a single product, highlights its advantages over the competition, and leads to a contact form allowing purchase of the product or registration for training, it’s difficult to consider such material solely educational.

In practice, entrepreneurs should remember that supervisory authorities analyze not only the content of the publication, but also its location, method of presentation and connection with the entrepreneur’s business activity.

Mistake #2 – Copying Cosmetic Product Marketing

The aesthetic medicine market is developing in parallel with the cosmetics market, resulting in many marketing activities being mutually inspired. However, from a regulatory perspective, this approach can lead to serious problems.

Cosmetics marketing relies primarily on building emotions, visual appeal, and creating a specific lifestyle. Meanwhile, communication regarding medical devices is subject to much more stringent requirements. Using identical marketing techniques for products covered by the MDR may lead to violations of advertising regulations, especially if the message ignores the limitations imposed by the product’s intended use or its method of use.

In practice, this means that the marketing department of a medical device manufacturer should not automatically use solutions used in cosmetic campaigns, even if they seem effective from a business point of view.

Mistake No. 3 – overexposing the effects of the treatment

Marketing materials for biostimulants often focus almost exclusively on aesthetic effects. Images depicting wrinkle smoothing, facial contour improvement, or increased skin firmness undoubtedly attract audiences and enhance the message’s appeal.

The problem, however, is that the results of aesthetic medicine treatments are individual. They depend on the patient’s age, health, skin condition, previous medical procedures, lifestyle, and the experience of the practitioner. Presenting individual, exceptionally positive results without proper context can lead to unrealistic expectations on the part of potential patients.

From a compliance perspective , it is much safer to present information about the mechanism of action of the product and its intended use than to focus all communication on spectacular visual effects.

Mistake No. 4 – Ignoring contraindications and limitations of use

Another common mistake is presenting a product solely through the lens of its benefits. Marketing materials often emphasize the product’s effectiveness, innovation, and safety, while failing to mention situations in which its use may be inadvisable.

Meanwhile, reliable communication regarding medical devices should also include information about contraindications, limitations of use, and the need for medical qualification. This doesn’t mean, of course, that every advertisement must include full instructions for use, but omitting all information regarding potential risks could lead to accusations of misleading consumers.

Mistake #5 – Lack of cooperation between marketing and legal departments

In many companies, marketing materials are prepared by external creative agencies or marketing departments that lack specialized knowledge of medical device regulations. Only then does the completed material reach the legal department, often just prior to publication.

affairs specialists and lawyers at the marketing campaign design stage. This avoids the need for later material withdrawal or costly modification.

Mistake #6 – Lack of social media procedures

Many companies have extensive procedures for approving product catalogs and printed materials, yet they don’t regulate the rules for publishing content on social media. Yet, it’s short posts on Instagram, Facebook, and LinkedIn that are currently published most frequently and have the greatest impact on a company’s image.

The lack of internal guidelines leads individual employees to publish content at their own discretion, often unaware of the legal consequences of using specific phrases or photographs. In practice, it’s worth developing separate policies for online communication, covering topics such as product presentation, use of photographic materials, publishing coverage of industry events, and collaborating with physicians and influencers.

Compliance practices – how to organize legal marketing communications?

Compliance system shouldn’t be limited to merely responding to emerging issues. Its primary goal is to prevent violations by establishing transparent rules for preparing and approving marketing materials.

In practice, a growing number of medical device manufacturers are implementing multi-stage approval procedures involving marketing departments, regulatory affairs specialists, quality control departments, and lawyers. This model allows for the assessment of a material not only in terms of its marketing appeal but also its compliance with the product’s technical documentation, instructions for use, and applicable regulations.

Maintaining documentation of the approval process is also particularly important. In the event of an audit, the company should be able to demonstrate that the materials were prepared in accordance with internal procedures and reviewed by appropriately qualified individuals. Archiving subsequent versions of materials, legal opinions, and publication decisions can be of significant evidentiary value.

In practice, a well-functioning compliance system shouldn’t be perceived as an obstacle to marketing activities. On the contrary, properly designed procedures enable legally secure communication, reducing the risk of administrative sanctions and disputes with supervisory authorities, while building trust with customers and business partners.

European perspective – why will the importance of compliance systematically grow?

Polish regulations on medical device advertising are currently among the most detailed in the European Union. However, this does not mean that businesses operating in the domestic market can limit themselves solely to knowledge of the provisions of the Medical Devices Act and the Regulation of the Minister of Health. The functioning of the medical devices market is increasingly determined by the practice of applying the MDR, the positions of EU bodies, and the actions of national regulatory authorities in individual member states.

The MDR does not contain comprehensive regulations on the advertising of medical devices. It focuses primarily on product safety, manufacturers’ obligations, conformity assessment, and the rules for placing devices on the market. At the same time, Article 7 of the MDR establishes the general principle that all communication about a device – regardless of its form – must not mislead users or patients about the product’s intended purpose, properties, safety, or efficacy.

In practice, this provision serves a much broader purpose than the classic ban on misleading advertising. It constitutes a specific interpretative principle that should be considered when assessing every form of communication conducted by a manufacturer or distributor. Increasingly, supervisory authorities are moving away from formalistic analysis of individual advertising slogans and focusing on the overall perception of the message by the average user.

At the same time, the activities of Medical Device Coordination Group (MDCG) highlights the growing importance of transparent information provided to users of medical devices. Although MDCG documents are not legally binding, in practice they guide the interpretation of MDR provisions by national authorities and notified bodies. Increasing emphasis is being placed on ensuring consistency between a device’s technical documentation, instructions for use, and market communications.

It can be predicted that in the coming years, marketing control will encompass not only traditional advertising but also recommendation algorithms of online platforms, message personalization, the use of artificial intelligence in marketing, and automated advertising profiles. The development of new technologies is blurring the lines between information, advertising, and educational content.

For manufacturers, this means moving away from a one-time approach to assessing marketing materials. Implementing ongoing compliance procedures that enable ongoing assessment of communications’ compliance with rapidly evolving regulatory requirements will be much more effective.

Practical checklist compliance before publishing marketing materials

In practice, most violations can be avoided by implementing simple verification procedures. Before publishing material regarding a medical device, it’s important to answer the following questions:

First, is the product intended for use by laypeople or exclusively by professionals? The answer to this question determines the acceptable scope of communication and the target audience.

Secondly, is the planned material truly informative, or is its primary purpose to increase interest in the product? When in doubt, it’s worth adopting a more cautious approach and evaluating the message according to advertising principles.

Third, are all claims regarding product properties supported by technical documentation, instructions for use, and conformity assessment results? Marketing departments should not independently make new claims regarding product effectiveness or safety.

Fourthly, does the material use evaluative terms such as “best”, “most effective”, “revolutionary” or “guaranteed effect”, the validity of which could be questioned by the supervisory authority?

Fifth, does the message include product use restrictions, the need for medical qualification, and other information relevant to user safety?

Sixth, does the publication contain photographs or recordings of patients? If so, it is necessary to verify not only compliance with regulations on advertising medical devices, but also the basis for processing personal data, the scope of consent granted, and the protection of personal rights.

Seventh, was the material reviewed by those responsible for regulatory and legal matters? In practice, even minor linguistic changes can significantly alter the legal assessment of the entire message.

Eighth, does the entrepreneur have documentation confirming the material approval process? In the event of an audit, the ability to demonstrate organizational diligence can be crucial to assessing the entrepreneur’s actions.

Summary

The development of the biostimulator market is one of the most dynamic areas in contemporary aesthetic medicine. These products respond to growing patient expectations for natural tissue regeneration methods, while simultaneously posing entirely new regulatory challenges for manufacturers, importers, distributors, and healthcare providers.

Contrary to popular belief, the biggest problem today isn’t the mere ability to advertise. The key challenge remains the ability to communicate effectively, while simultaneously providing accurate product information and complying with stringent legal requirements. The line between information and advertising is becoming increasingly blurred, especially in the digital environment, where communication occurs via social media, educational platforms, and artificial intelligence tools.

From the perspective of entrepreneurs, this means a shift in thinking about medical device marketing. Instead of treating compliance as a final stage of reviewing advertising materials, it’s worth viewing them as an integral element of the process of designing market communication. Early involvement of legal, regulatory, and quality specialists not only reduces the risk of administrative sanctions but also builds brand credibility and audience trust.

It can be expected that the requirements for communication transparency will systematically increase in the coming years. The development of artificial intelligence, data-driven marketing, and message personalization will force supervisory authorities to increasingly scrutinize not only the content of advertisements but also their distribution and impact on audience decisions. In this environment, competitive advantage will be achieved not by those businesses that conduct the most aggressive marketing communications, but by those that manage to combine innovation with regulatory responsibility.

Artykuł Biostimulants under the microscope of the law – where does information end and prohibited advertising of medical devices begin? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

We are delighted to share an important milestone in the continued development of KG Legal’s Data, AI & Cybersecurity Desk.

It has been a great honour to serve as the exclusive expert contributors for Poland to the OneTrust DataGuidance Privacy Overview – Poland, one of the world’s leading professional legal compliance resources relied upon by in-house counsel, privacy professionals, compliance officers, multinational organisations and technology companies operating across multiple jurisdictions.

Preparing this contribution was a long-term project that required several months of intensive legal analysis, research and editorial work. Our objective was not simply to describe the application of the GDPR in Poland. Instead, we sought to create a practical and comprehensive guide reflecting the significant transformation of the Polish regulatory landscape that has taken place in recent years as a result of new European legislation and its implementation into Polish law.

The publication therefore extends far beyond a traditional overview of Polish data protection law. It examines the interaction between privacy, digital regulation, cybersecurity and artificial intelligence, providing readers with practical guidance on the most important legal developments affecting organisations operating in Poland.

Our contribution discusses, among other things:

• the practical application of the GDPR within the Polish legal system;
• the powers and regulatory practice of the Polish supervisory authority for personal data protection;
• employee monitoring and workplace privacy;
• cookies, consent mechanisms and online tracking technologies;
• electronic communications and direct marketing requirements;
• international data transfers;
• personal data breaches and notification obligations;
• practical compliance with Polish privacy legislation;
• cybersecurity-related regulatory developments;
• the growing interaction between data protection and artificial intelligence governance.

A particularly important aspect of this work was addressing the rapidly evolving legislative environment. During the last few years, Poland has experienced substantial regulatory changes resulting from the implementation of numerous European legal instruments and the entry into force of directly applicable EU regulations that significantly affect organisations processing personal data.

Accordingly, the publication takes into account the practical implications of the evolving European digital regulatory framework, including the interaction between the GDPR and newer legal instruments governing digital services, artificial intelligence, cybersecurity and data governance. The analysis also reflects the impact of the AI regulatory framework, developments concerning data governance and electronic communications, as well as the increasingly interconnected compliance obligations facing businesses operating in today’s digital economy.

Rather than presenting legislation in isolation, the publication adopts a practical, compliance-oriented perspective. It combines:

• the GDPR and Polish implementing legislation;
• guidance issued by the European Data Protection Board (EDPB);
• the jurisprudence of the Court of Justice of the European Union;
• decisions and regulatory guidance published by the Polish Personal Data Protection Office (UODO);
• recent Polish legislative developments and market practice.

Our ambition was to create a resource that would assist both international and domestic organisations in navigating one of the fastest-changing areas of European regulation, where privacy law increasingly intersects with cybersecurity, AI governance, digital platforms, online communications and emerging technologies.

The contribution was prepared by Małgorzata Kiełtyka and Jakub Gładkowski, whose combined experience covers complex cross-border advisory work in data protection, artificial intelligence, life sciences, healthcare, technology law, cybersecurity, intellectual property and regulatory compliance.

https://www.dataguidance.com/experts-directory/Jakub_G%C5%82adkowski

https://www.dataguidance.com/experts-directory/Malgorzata_Kieltyka

For many years, Małgorzata Kiełtyka has advised international companies on GDPR compliance, healthcare regulation, AI governance, technology transactions and cross-border regulatory matters. Her practice combines strategic legal advice with practical implementation of compliance frameworks for multinational businesses operating in highly regulated sectors.

Jakub Gładkowski focuses on data protection, digital regulation, cybersecurity, intellectual property, IT law and emerging technologies. His practice includes advising innovative businesses on regulatory compliance, digital transformation projects and the implementation of European technology legislation affecting both public and private sector organisations.

Being entrusted with preparing Poland’s national contribution to OneTrust DataGuidance represents an important recognition of our team’s expertise and international standing. We are particularly proud that this publication reflects not only our experience in privacy law, but also our broader interdisciplinary approach, integrating data protection with AI regulation, cybersecurity, digital compliance and technology law.

We sincerely thank the editorial team at OneTrust DataGuidance for their confidence in our expertise and for the opportunity to contribute to a publication that supports legal and compliance professionals around the world.

For KG Legal, this publication marks another significant milestone in the continued growth of our Data, AI & Cybersecurity Desk and reinforces our commitment to delivering practical, business-oriented legal advice at the intersection of privacy, technology and innovation.

Artykuł A Major Milestone for KG Legal’s Data, AI & Cybersecurity Practice: Exclusive Poland Contribution to OneTrust DataGuidance pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Polish judicial protection tools for the sale of real estate in international bankruptcy – case study and suggested solutions

In the Polish legal system, it is possible to extend bankruptcy declared abroad to Polish jurisdiction. In accordance with the amendment to the Polish Bankruptcy Law, which came into force on January 1, 2016, the provisions of the Act update the possibility of recognizing judgments initiating foreign bankruptcy proceedings. This is related, among other things, to increased emphasis on the universality of bankruptcy proceedings, especially in European Union countries. Pursuant to Article 19 of Regulation 2015/848 of the European Parliament and of the Council, “a judgment opening insolvency proceedings issued by a court of a Member State having jurisdiction in accordance with Art. 3 shall be recognized in all other Member States (…).” The phrase “having jurisdiction in accordance with Art. 3” – art. 3 of the Regulation reads: “1. The courts of the Member State in whose territory the debtor’s center of main interests is situated have jurisdiction to open insolvency proceedings – the main insolvency proceedings. The main bankruptcy proceedings are considered to be proceedings initiated in the country where the principal center of the debtor’s main activities is located (Article 3(1) of the Regulation)[1].

However, “the main center of basic activity is the place where the debtor regularly manages its economic activities and which, as such, is recognizable to third parties” – the quoted fragment directly describes the concept of COMI[2] and clearly defines the scope of the courts’ jurisdiction in this respect. Moreover, this provision primarily introduces the principle according to which judgments issued outside Poland also have effects within the territory of Poland, which makes it possible to satisfy the debtor’s creditors from assets also located within the territory of the Republic of Poland. Because pursuant to Art. 382(2) of the Polish Bankruptcy Law, Polish courts also have jurisdiction if the debtor runs a business in the Republic of Poland or has his place of residence or registered office or assets. Regulation 2015/848 also demarcates the territorial scope of application of the regulations of individual jurisdictions[3]. Recognition by a Polish court of a judgment to initiate foreign bankruptcy proceedings has ex tunc effects in the Polish legal order in relation to the judgment of a foreign court[4]. Consequently, the opening of foreign proceedings abroad has simultaneous effects in Poland when they become final. This mechanism effectively secures the legal interests of both domestic creditors and those located outside Poland. Initiation of such proceedings in accordance with Art. 386(1) of the Polish Bankruptcy Law takes place at the request of the foreign administrator or debtor. It is also worth pointing out that in accordance with Art. 392 of the bankruptcy law, “a judgment on the initiation of foreign bankruptcy proceedings is subject to recognition if: 1) it concerns a matter that does not fall within the exclusive jurisdiction of Polish courts; 2) recognition is not contrary to the fundamental principles of the legal order in the Republic of Poland. Judgments that are contrary to the basic principles of the legal order in the Republic of Poland are those that do not correspond to the main fundamental constitutional principles and the basic principles governing individual areas of law[5]. What is also worth mentioning is Art. 403 section 1 of the Polish Bankruptcy Law, according to which the effects of declaring bankruptcy regarding the bankrupt’s assets located in Poland and obligations that arose or are to be performed in Poland are assessed in accordance with Polish law. Therefore, in order to be able to satisfy foreign creditors from assets located in Poland, the foreign equivalent of the Polish trustee is obliged to submit an application to a Polish court for the recognition of the foreign judgment and the appointment of a Polish court supervisor who will supervise the course of proceedings within the scope of Polish jurisdiction regarding the property belonging to part of the insolvency estate and located in the territory of the Republic of Poland.

Case study

Using the experience of KIELTYKA GLADKOWSKI KG LEGAL, let us analyse a situation in which a dishonest debtor sold his real estate that formed a part of the bankruptcy estate. The facts were as follows: the Polish citizen ran his own business, the main center of which was located in the United Kingdom. It is worth noting here that the declaration of foreign bankruptcy took place before the United Kingdom left the European Union. In connection with running business activity, the debtor incurred liabilities that he did not settle, including public liabilities (tax, insurance). Therefore, due to the fact that the business was conducted in the UK, bankruptcy proceedings were initiated in this country. In the course of the activities carried out, it was shown that the debtor’s property included in the bankruptcy estate is real estate located in Poland. Therefore, in order to satisfy the creditors, there has been filed an application to the Court in Poland to recognize the opening of foreign bankruptcy proceedings and appoint a court supervisor in Poland. The bankrupt did not raise any objections about the existence of the debt, bankruptcy proceedings or the fact that the debtor owned real estate in Poland. Therefore, the debtor was aware of his obligations, and it should be noted that the debtor actively participated in both the proceedings before the British court and the Polish court in the process of recognizing the foreign judgment. At the same time, before the final recognition of the opening of foreign bankruptcy proceedings, the bankrupt sold real estate which should have been included in the bankruptcy estate. Due to the fact that the debtor lost the management of the property when bankruptcy proceedings were opened in the United Kingdom, the debtor could not legally dispose of the property because such an action would result in harm to creditors. Due to the defective action, the entire situation was further complicated by the fact that a limited property right was established against the new owners, i.e. a mortgage in favour of the bank from which the new owners took out a mortgage loan. In the light of the provisions of limited property law, the new owners submitted a declaration to which they were not entitled by operation of law, pursuant to Art. 245 of the Polish Civil Code, which states that only the owner of the property may make a declaration establishing a mortgage in the form of a notarial deed. The fact that the property was purchased invalidly should result in the invalidity of the mortgage, which proves the discrepancy between the status disclosed in the land and mortgage register and the actual legal status.

On the basis of the provisions contained in the Polish Civil Code, it could be demonstrated that the debtor’s action was ineffective, although in order to demonstrate that such an action does not produce legal effects, the creditor would have to demand this state of affairs before the court. If the bankrupt had performed an action before the court in the United Kingdom issued a judgment, the actions performed against the bankruptcy estate could be said to be ineffective, however, in the case described above, the provisions of bankruptcy law are applicable, which constitute the lex specialis, therefore they have priority over the provisions of the Civil Code. Polish Article 77 of the bankruptcy law states directly that “the bankrupt’s legal actions regarding property included in the bankruptcy estate are invalid by the operation of law”, it should be emphasized that these actions are invalid ab initio, that is, they do not produce legal effects from the moment the action is taken, and, moreover, for the invalidity to occur, it is not necessary for the parties to submit a declaration or obtain a constitutive court decision[6]. Moreover, invalidity operates erga omnes, i.e. “everyone may invoke it (that is, the parties to the invalid legal transaction, their legal successors, creditors and other persons who have a legal interest in it), and it is of a definitive nature, i.e. the legal form does not become valid when the reasons for invalidity are no longer valid, it is not subject to validation[7]. If the bankrupt sells the real estate that belongs to the bankruptcy estate after the declaration of bankruptcy, such an action is absolutely invalid, the contract of transfer of ownership does not produce legal effects, and what is more, this state of affairs does not need to be pursued in court, because invalidity results from the very force of law. It is worth emphasizing here that the provisions on the protection of persons in good faith for actions performed by a bankrupt who has lost the right of administration of assets in accordance with Art. 75 of the bankruptcy law do not apply, because otherwise it could lead to a reduction of the bankruptcy estate and infringement of the interests of creditors[8], and thus it would lead to actions contrary to the main purpose of bankruptcy proceedings, which is to satisfy creditors to the highest possible extent.

An alternative solution to protect creditors is a lawsuit to reconcile the content of land and mortgage registers with the actual legal status of a given property. The institution of such a lawsuit allows to restore the previous state disclosed in the land and mortgage register, so that a possible new buyer will no longer be able to dispose of the property belonging to the bankruptcy estate. Pursuant to Art. 10 of the Polish Land and Mortgage Register Act, in the event of a discrepancy between the legal status of the property disclosed in the land and mortgage register and the actual legal status, claims may be brought before the court to remove such discrepancy. In the standard procedure, the burden of refuting the proof of the presumption resulting from the entry in the land and mortgage register rests with the plaintiff, however, if the defendant is a buyer who acquired ownership of the real estate by way of an invalid contract, such an obligation will rest with him, and what is more, the situation of such a buyer cannot be protected under Art. 5 of the Polish Act on land and mortgage registers, the institution of the guarantee of public faith in land and mortgage registers. According to the judgment of the Polish Supreme Court[9], the warranty of public faith in land and mortgage registers does not protect the buyer if the agreement on the transfer of ownership of the real estate was invalid. It is worth pointing out here that while the institution of actio pauliana resulting from Art. 527 of the Civil Code, is subject to a deadline which, in accordance with Art. 534 of the Civil Code specifies that after 5 years from the date of an invalid act (transfer of ownership of real estate), one cannot demand that this legal act be recognized as having been performed to the detriment of creditors and as ineffective, in the case of a lawsuit under Art. 10(1) of the Polish Act on Land and Mortgage Registers, the claim for reconciliation of the legal status disclosed in the land and mortgage register with the actual legal status is not time-barred[10]. Despite the existence of such an institution, it should be concluded that bankruptcy proceedings have a wider range of possibilities in terms of eliminating incorrect decisions made by the bankrupt, because when applying Art. 77 of the Polish bankruptcy law, we do not deal with possible barriers resulting from the warranty of public faith in land and mortgage registers through the application of Art. 10 of the Polish Act on Land and Mortgage Registers, including the locus standi of the plaintiff – which states that an action to remove the inconsistency between the legal status of real estate disclosed in the land and mortgage register and the actual legal status may be brought only by an entity authorized to submit an application for an entry in the land and mortgage register (Art. 10 of the Land and Mortgage Registers Act and Article 626² § 5 of the Code of Civil Procedure).

            To sum up, the available judicial protection tools securing the interests of creditors in cross border insolvency and restructuring provide numerous solutions that can be appropriately applied depending on the complexity of the case and the specific factual situation. Nevertheless, some legal instruments are characterized by greater or lesser difficulties in their application, which may turn out to be insurmountable in the course of the case, it is important to select appropriate tools for a specific situation, so that creditors, in accordance with the main function of bankruptcy proceedings, are satisfied to the highest degree.

Bibliography:

1. Janda P. [in:] Bankruptcy law. Commentary, ed. III, Warsaw 2023.
2. Jelonek-Jarco B., 4.2.2. Invalidity of a legal act resulting from Art. 77 of bankruptcy law [in:] Warranty of public faith in land and mortgage registers, Warsaw, 2011.
3. Sierakowski B., Waberski M., Recognition of a decision to initiate foreign bankruptcy proceedings [in:] Judicial and procedural capacity of the party (natural and legal person) against whom a decision to initiate bankruptcy proceedings was issued in a country outside the European Union – scope of application of the personal and legal bankruptcy statute, Private Law, Warsaw, 2022.
4. Stelmach B., Interpretation of the concept of “invalidity” – selected issues, Palestra 5-6/2015.
5. Tim A., Consumer bankruptcy in Polish and German law and the practice of forum shopping, Internetowy Kwartalnik Antymonopolowy i Regulacyjny [Online Antitrust and Regulatory Quarterly] 2018, no. 6(7).
6. Zedler F., Recognition of foreign bankruptcy proceedings in European law, Legal, economic and sociological movement Year LXVII, issue 2, 2005.

[1]F. Zedler, Recognition of foreign bankruptcy proceedings in European law, Legal, economic and sociological movement Year LXVII, issue 2, 2005, p. 64.

[2]Center of Main Interests – The main center of the debtor’s primary activities.

[3]A. Tim, Consumer bankruptcy in Polish and German law and the practice of forum shopping, Internetowy Kwartalnik Antymonopolowy and Regulacyjny [Online Antitrust and Regulatory Quarterly] 2018, no. 6 (7), p. 61.

[4]B. Sierakowski, M. Waberski, Recognition of the decision to initiate foreign bankruptcy proceedings [in:] Judicial and procedural capacity of the party (natural and legal person) against whom a decision to initiate bankruptcy proceedings was issued in a country outside the European Union – scope of application of the personal and legal bankruptcy statute, Private Law, Warsaw, 2022, p. 24.

[5]P. Janda [in:] Bankruptcy law. Commentary, ed. III , Warsaw 2023, art. 392.

[6]B. Stelmach, Interpretation of the concept of “invalidity” – selected issues, Palestra 5-6/2015.

[7]Judgment of the Supreme Court of January 12, 2022, II CSKP 212/22.

[8]B. Jelonek-Jarco, 4.2.2. Invalidity of a legal act resulting from Article 77 of the bankruptcy law [in:] Warranty of public faith in land and mortgage registers, Warsaw, 2011.

[9]Judgment of the Supreme Court of January 24, 2002, III CKN 405/99.

[10]Judgment of the Supreme Court judgment of June 26, 1974, II Cr 326/74.

Artykuł Debtor hiding real estate from a foreign creditor in bankruptcy proceedings in Poland – legal solutions to help creditors pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On January 15, 2024, there will be held the event KRAKÓW: City – space for business. Synergy for the reconstruction of Ukraine. The event is organized by the Polis-Ukrainian Chamber of Commerce within the framework of the social campaign “Partnership and Employment” and the project “Work for Reconstruction of Entrepreneurship in Ukraine.” The event will provide a unique platform for diverse professionals, thought leaders, and stakeholders to come together and discuss critical issues surrounding urban development, business opportunities, and collaborative efforts for the reconstruction of Ukraine. The conference will cover a wide range of topics such as urban planning, sustainable development, and the role of businesses in contributing to the reconstruction efforts in Ukraine. Renowned experts and speakers will share valuable insights, best practices, and innovative ideas, fostering a rich exchange of knowledge and experience. Participation in the Conference will be an enriching experience. The insights we will gain and connections made will undoubtedly contribute to our professional growth. The event will be participated by Weronika Mazurek on behalf of KIELTYKA GLADKOWSKI KG LEGAL.

• Lootboxes in Computer Games – Between Gambling Law and Consumer Protection. Regulatory Analysis Against the Background of Polish and European Union Law.
  July 24, 2026
  Publication date: July 24, 2026 The dynamic development of the computer games market has led to a significant change in the monetization models used by game producers and publishers. The traditional sales model, based on a one-time purchase of a product by the consumer, has been largely replaced by solutions based on long-term user engagement […]
• A Store in Your Pocket, the Law in the Background: TikTok Shop Under the Regulators’ Lens
  July 24, 2026
  Publication date: July 24, 2026 You see a video, a product catches your eye, and an “add to cart” button is already blinking in the corner of the screen. A few seconds later the order is placed, paid for, and on its way — all without leaving the app. That’s how TikTok Shop works: a […]
• Kiełtyka Gładkowski KG Legal has published an expert contribution in Infor, devoted to loot boxes in video games
  July 24, 2026
  Publication date: July 24, 2026 We are pleased to share that Kiełtyka Gładkowski KG Legal has published an expert contribution in Infor, one of Poland’s leading legal and financial publications, devoted to one of the most intriguing regulatory phenomena of the digital economy: loot boxes in video games. “Loot boxes in video games: between gambling […]
• Criminal Procedure Reform (Project 1600) – Polish Standards of Protection in Commercial Matters
  July 24, 2026
  Publication date: July 24, 2026 Analysis of key changes for business managers We have analyzed the proposed changes to criminal procedure, which introduce a new structure for conducting proceedings, moving away from the current, restrictive model. The foundation of the amendment is the liberalization of regulations and the strengthening of procedural guarantees for suspects, which […]
• Biostimulants under the microscope of the law – where does information end and prohibited advertising of medical devices begin?
  July 24, 2026
  Publication date: July 24, 2026 Biostimulants in aesthetic medicine – current regulatory challenges for manufacturers, distributors and clinics The aesthetic medicine market is currently one of the fastest-growing healthcare segments in Europe. Particularly dynamic growth is observed in so-called tissue biostimulants, preparations used to stimulate the body’s natural regenerative processes. While traditional fillers dominated just […]
• A well-aimed shot at American e-commerce. A practical guide to customs clearance of US shipments through the Polish Post.
  July 24, 2026
  Publication date: July 24, 2026 Jan K., a literature enthusiast with an extraordinary fondness for Polish children’s poetry, finally managed to find a very rare book after a long search – an edition of Julian Tuwim’s “Locomotive,” which he purchased without hesitation from a used bookstore in Maryland, USA, via the online platform AbeBooks. The […]
• Summer holidays? Not for our litigation team. We are preparing a dispute before the EU General Court
  July 24, 2026
  Publication date: July 24, 2026 The holiday season is in full swing, but our litigation team remains fully alert — and fully engaged. The best proof: ongoing preparations for proceedings before the General Court of the European Union in Luxembourg in one of the most complex categories of disputes — EU grant litigation. What is […]
• Faking reviews in e-commerce – analysis of new legal regulations, algorithmic mechanisms and market practices in the e-commerce sector
  July 10, 2026
  Publication date: July 10, 2026 The phenomenon of fake reviews in the digital space has evolved from a marginal image issue to a central focus of market supervision authorities and EU legislators. The contemporary ontology of this phenomenon extends beyond primitive content fabrication to encompass any form of communication that, by distorting the actual consumer […]
• NOTE – EU Cloud and AI Development Act (CADA) project and the concept of the sovereign cloud in the European Union’s digital policy
  July 10, 2026
  Publication date: July 10, 2026 I. Introduction On June 3, 2026, the European Commission adopted a proposal for the Cloud and AI Development Act (hereinafter: CADA or the draft), which is the centerpiece of the broader European Technological Sovereignty Package. This draft seeks to translate the political concept of digital sovereignty into binding legal standards […]
• CLIENT ALERT Dietary supplements market in Poland Amendments to food safety regulations | May 2026
  July 8, 2026
  Publication date: July 07, 2026 The draft Act of April 13, 2026, amending the Act on Food and Nutrition Safety will enter into force six months after its publication. The new regulations primarily impact producers, importers, distributors, and sellers of dietary supplements – both in traditional and online channels. Below, we present the real changes […]

Artykuł <strong>KIELTYKA GLADKOWSKI KG LEGAL TAKES PART IN THE EVENT “KRAKÓW: City – space for business. Synergy for the reconstruction of Ukraine”, January 15, 2024</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Polish energy law has been amended.

If you interested in new regulations you can find link to the text and our video presenting new regulations HERE.

Artykuł KG Legal cooperates with Scandinavian law firm pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On 19th May 2017 KG Legal participated in the BioLawEurope annual general meeting in Paris and was represented by its associate Kamil Trzaskoś, whose specialisations focus on IT and Patent law. During the meeting numbers of specialists from all around the world have been debating about development directions, admission of new members and possibilities of further cooperation. 

The special guest, Brian Hand presented the Trumpcare reform and compared it with the Obamacare concept. After an official part of the meeting, which took place in the Hotel Regina in Paris, the representatives of law firms had an opportunity to participate together in a dinner organized in the Le train bleu restaurant on Gare de Lyon.

Artykuł BioLawEurope annual general meeting has finished pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.