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.

Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) are twin regulations issued on the same day, aimed at regulating medical devices sold in the European Union. The MDR governs the making available on the market, placing on the market, and use of medical devices. The IVDR establishes the same framework for in vitro diagnostic medical devices, but also covers the rules for marketing these products (including complaints and adverse reactions).

Although these regulations have been in force for several years, they are entering the market in stages. At the time of writing (January 2026), some provisions from the most recent amendment (in 2024) had not yet entered into force. This is due to the complexity of the regulations, which made compliance difficult for many entities. However, the two amendments proved insufficient, and the Commission submitted a proposal for another amendment in December 2025.

The MDR regulates medical devices, which can be any instrument, apparatus, device, software, implant, in vitro reagent, or other material or article intended by the manufacturer to be used—alone or in combination with other materials or articles—in humans for a medical purpose, such as diagnosing, treating, mitigating, preventing, monitoring, predicting, or prognosing a disease, injury, or other condition. This is therefore a very broad definition, encompassing very simple products, from surgical masks to implantable cardiac pacemakers. They are regulated based on the risk they may pose and their intended purpose, dividing products into four classes. Initially, the regulations introduced strict requirements and a rigorous conformity assessment system to ensure the high quality and safety of products placed on the EU market. Due to the low number of notified bodies at the time of their introduction, the certification process was very difficult. However, this problem has now been resolved. However, other issues remain, prompting the need for further amendment. This article aims to present the reasons and objectives of the proposed changes, outline the changes themselves, and attempt to describe their main consequences.

Reasons and goals of change

In its document outlining the proposed changes, the Commission also outlined the reasons for the proposed changes in bold. The primary goal is to streamline and adapt the regulatory framework to future challenges. In its current form, the regulations impose significant administrative burdens on manufacturers, creating unpredictable rules and complex and cost-ineffective certification procedures. Furthermore, the changes aim to adapt the rules to market realities, as some provisions are currently perceived as disproportionate to the actual risks posed by products.

Overly burdensome requirements can induce manufacturers to discontinue supplying devices or delay their introduction to the market, which can have negative consequences for patient care and public health. They can also negatively impact the competitiveness of the EU medical devices market vis-à-vis other jurisdictions. Current rules, considered fragmented and non-harmonized, have led to a number of inefficiencies and unnecessary burdens for stakeholders (primarily manufacturers). According to the Commission, the administrative burden stems from reporting requirements and duplication of work, which is particularly burdensome for small and medium-sized enterprises (SMEs). In addition to reducing market competition, unclear rules also reduce support for innovation, which requires supportive and flexible mechanisms. Regulations result in disproportionate costs for manufacturers, especially SMEs.

An important aspect of the proposed changes is the attempt to create a more centralized approach and greater involvement of notified bodies in the conformity assessment procedure. Currently, many of these issues are left to the discretion of Member States. The Medical Device Coordination Group (MDCG), established under Article 103 of the MDR, will be retained as the main governing body. However, it will be closely monitored by experts from the Commission. The changes are generally aimed at increasing expert involvement.

The desire to implement the changes stems from an evaluation conducted by the Commission, as well as an evaluation to which stakeholders – including manufacturers – were invited. This evaluation revealed that the problems identified by the Commission are shared by market participants, who also agree with the proposed changes. However, it is crucial that the benefits for patients and healthcare systems – strengthening the safety and performance of devices and increasing transparency – remain the primary goal. Nevertheless, it is estimated that the changes will continue to ensure patient safety while achieving a measurable impact of approximately €3 billion.

Description of the proposed changes

Following consultations and its own evaluation of the MDR and IVDR, the Commission is proposing a number of changes, which are discussed below. In addition to the changes to the MDR and IVDR, the proposal includes minor changes to Regulation 2002/123 on crisis preparedness for medical products and Regulation 2002/1689 on artificial intelligence. The Commission has divided the proposed changes to the MDR and IVDR into eight sections and will be described in this article.

Issue 1: Simplification and Proportionality

The Commission proposes to remove the detailed requirements for the qualification of the person responsible for regulatory compliance (PRRC) and to remove the obligation for SMEs using an external PRRC to have it available “permanently and continuously” – it is sufficient that it is only available [Article 15 MDR; Article 15 IVDR]. The maximum validity period of certificates (currently 5 years) will be abolished. Instead of recertifying devices, notified bodies will conduct periodic reviews proportionate to the risk of the device during the validity of the certificate [Article 56 MDR; Article 51 IVDR]. A broader range of data will be considered clinical data. The conditions for relying on clinical data of an equivalent device will become more flexible. Article 61 MDR plans to extend the possibility of demonstrating the safety and performance of a device solely on the basis of non-clinical data. The use of “New Approach Methodologies” such as in silico studies is promoted [Article 2(48), Article 6, Annex II and XIV MDR; Annex XIII of the IVDR]. A definition of “well-established technology device” will be introduced for devices, which will be subject to more proportionate requirements, replacing the lists of devices in the current Articles 18(3), 52(4) and 61(6)(b) of the MDR [Article 2(72), Article 18, Article 32, Article 52, Article 61 and Article 86 of the MDR].

The requirement for a notified body certificate for relabelling and repackaging activities, as well as the obligation for prior notification, is to be removed [Article 16 of the MDR; Article 16 of the IVDR]. Some classification rules are to be adapted, resulting in lower risk classes for certain devices, such as reusable surgical instruments, accessories to active implantable devices and software [Annex VIII of the MDR].

Issue 2: Reducing administrative burden

The scope of devices for which the manufacturer must provide a summary of safety and (clinical) performance (SS(C)P) will be limited to devices for which a notified body must carry out an assessment of the technical documentation. Because the draft SS(C)P is part of the documentation submitted to the notified body, separate validation by the notified body will no longer be required [MDR Article 32; IVDR Article 29]. The frequency with which manufacturers are required to update periodic safety update reports (PSURs) will be reduced. The review of PSURs by the notified body will be part of its supervisory activities [MDR Article 86; IVDR Article 81]. Manufacturers will have 30 days (instead of 15 days) to report serious incidents that are not associated with risks to public health, death or serious deterioration in state of health [MDR Article 87; IVDR Article 82]. The notified body will have to distinguish between changes to the quality management system or the approved device that manufacturers may implement without prior notification, without prior approval, or only after approval by the notified body. Where appropriate, the notified body and the manufacturer will have to agree on an established change control plan [Annex VII of the MDR; Annex VII of the IVDR]. Finally, performance studies involving only routine blood sampling will no longer be subject to prior approval. The obligation to notify performance studies on companion diagnostics using leftover samples will be removed [Article 58 of the IVDR].

Issue 3: covering innovation and product availability for specific patient groups and situations

The conditions for manufacturing and use in healthcare facilities are to be made more flexible (e.g., allowing the transfer of proprietary devices if this is in the interest of patient safety or public health). The IVDR is to remove the requirement that there is no suitable equivalent device on the market. Central laboratories manufacturing and using tests exclusively for clinical trials will be added to the scope of the waiver for proprietary devices [Article 5(5) of the MDR; Article 5(5) of the IVDR]. A central IT tool for reporting and information exchange will be made available in the Eudamed database or will be interoperable with it. The EMA (European Medicines Agency) will develop a methodology for identifying devices subject to the reporting obligation and compile a list of such devices [Article 10a of the MDR; Article 10a of the IVDR]. Criteria for breakthrough and orphan devices will be introduced. After “designation” by an expert panel, breakthrough and orphan devices will be subject to priority and rolling review. Manufacturers will have access to advice from expert panels [new Article 52a of the MDR; new Art. 48a IVDR]. The Commission will be able to authorize the placing on the market of devices on its own initiative in the event of a public health emergency. Competent authorities will be able to authorize derogations regarding the manufacture, design or intended purpose of CE marked devices during serious cross-border health threats, disasters or crises [Art. 59 and new Art. 59a MDR; Art. 54 and new Art. 54a IVDR]. Member States and the Commission will be able to establish regulatory sandboxes to meet the needs of emerging technologies [new Art. 59b and new Art. 59c MDR; new Art. 54b and new Art. 54c IVDR]. Manufacturers will be required to provide justification for the “single use” designation. All devices that are not intended for single use may be reprocessed in accordance with the instructions provided by the manufacturer. A person who fully reprocesses a single-use device will be considered the manufacturer of that device. This provision will apply five years after the entry into force of [Art. 17 MDR]. Clarification will be provided regarding the composition of kits as defined in Art. 2(11) IVDR [new Art. 19a IVDR]. Orphan devices that were CE marked under the old directives and for which an expert panel confirmed that they meet the criteria for an “orphan device” may continue to be placed on the market after the transitional periods, under certain conditions [Art. 120 MDR; Art. 110 IVDR]. The outdated definition of nanomaterial in Art. 2 MDR will be deleted and replaced by a reference to the Commission Recommendation of 10 June 2022 on the definition of nanomaterial in the provisions of Annex I and Annex VIII on nanomaterials [Annex I and Annex VIII MDR].

Issue 4: Regarding the predictability and profitability of certification

A legal basis will be introduced for notified bodies and manufacturers to conduct a structured dialogue, based on documented procedures, before and after the submission of an application [Annex VII of the MDR; Annex VII of the IVDR]. Notified bodies’ involvement in the conformity assessment of low- and medium-risk devices (classes IIa and IIb, and class B and C) will be reduced (assessing the technical documentation of one representative device for a generic group of devices, for a category, or for an entire portfolio). Systematic assessment of the technical documentation of representative devices will not be required during surveillance activities. Sterile IVD class A devices will not require the involvement of a notified body. Notified bodies will have the option of replacing on-site audits with remote audits. Where justified by the absence of safety concerns, surveillance audits should be conducted only every two years. Unannounced audits should be conducted “for -cause.” The timeframes for consultations with authorities for medicinal products and SoHO (substances of human origin) are to be shortened [Article 52, Annex IX, Annex X, and Annex XI MDR; Article 48, Annex IX, Annex X, and Annex XI IVDR]. The scope of the CECP will be limited to class III implantable devices, with the Commission being empowered to add other device types by delegated act. The Performance Evaluation Consultation Procedure (PECP) will be removed. Instead, the possibility of obtaining early advice from expert panels will be introduced for class C and D IVD devices [Article 54 MDR; Article 48 and new Article 56a IVDR]. Fees for micro and small manufacturers and for orphan devices are to be reduced. The Commission is to be empowered to determine the level and structure of fees for notified bodies [Article 50 MDR].

Issue 5: Coordinating within a decentralized system

Coordination between competent authorities regarding product qualification and device classification (the “Helsinki procedure”) is to be codified, with the possibility of requesting opinions from expert panels [Article 4, new Article 4a, new Article 51a and new Article 51b MDR; Article 3, new Article 3a, new Article 47a and new Article 47b IVDR]. The assessment of applications from conformity assessment bodies and the designation/notification of notified bodies is to be streamlined with the participation of joint assessment teams consisting of the national authority responsible for notified bodies, experts appointed by the Commission, and experts appointed by other Member States. Joint assessment teams will be involved in the monitoring of notified bodies after their designation, at least every two years. The full re-assessment of notified bodies every five years will be deleted. The Commission will be empowered to determine the level and structure of fees and recoverable costs for the designation and monitoring of notified bodies [Article 36-44 MDR; Art. 31 IVDR]. The authority responsible for notified bodies will act as an “ombudsman” in the event of disputes between manufacturers and notified bodies [Art. 35 MDR; Art. 31 IVDR]. The obligation for notified bodies to participate in the notified body coordination group (NBCG-Med) is to be strengthened. NBCG-Med will report to the MDCG [Art. 49 MDR; Art. 31 IVDR]. The role of expert panels and their composition is to be expanded, involving them, among other things, in determining the regulatory status of products and device classification. Expert panels should be able to provide scientific, technical, clinical and regulatory advice to the Commission, Member States, the MDCG, notified bodies and, in some cases, manufacturers. The EMA will continue to provide the secretariat for the expert panels. The functions of expert panels and expert laboratories, currently regulated jointly in Article 106 of the MDR, will be clarified through a separate provision on expert laboratories [Article 106 and new Article 106a of the MDR; Article 100 of the IVDR]. The EMA will provide scientific, technical, and administrative support for coordination between national competent authorities in several areas, such as borderline cases and classification, multi-center clinical trials, derogations, vigilance, and market surveillance. The EMA will also provide support for SMEs [new Article 106b of the MDR].

Issue 6: relating to further digitalization

The EU declaration of conformity will be able to be provided digitally. Subject to future implementing rules, certain labeling information will be able to be provided digitally. Manufacturers of near-patient tests will be able to provide electronic instructions for use. Information under the MDR/IVDR will be submitted electronically. Economic operators must provide their digital contact in Eudamed [Article 19, new Article 110a, Annex I and Annex VI of the MDR; Article 17, new Article 103a, Annex I Annex VI of the IVDR]. Manufacturers will be able to produce technical documentation, reports, and other documents in digital form [new Article 52b of the MDR; new Article 48b of the IVDR]. For online sales, certain essential information necessary for device identification and instructions for use will have to be provided [Article 6 of the MDR; Article 6 of the IVDR]. The provisions on UDI assignment and registration in Eudamed are to be clarified. It is to be possible to create certain electronic systems outside the Eudamed database [Articles 27-33 and Annex VII of the MDR; Articles 24-30 and Annex VII of the IVDR].

Issue 7: On International Cooperation

A new section on international cooperation is to be introduced to promote activities aimed at global regulatory convergence and international cooperation, such as the International Medical Device Regulators Forum (IMDRF) and the Joint Medical Device Audit Programme (MDSAP) [new Article 108a and new Article 108b of the MDR].

Issue 8: Relationship to other EU regulations

For combined trials, the sponsor will be able to submit a single application, which will trigger a coordinated assessment under Regulation (EU) No 536/2014 on clinical trials, as amended accordingly by the Biotech Act (new Article 79a MDR; new Article 75a IVDR). Serious incidents reported under the vigilance system established under the MDR or IVDR that also qualify as actively exploited vulnerabilities (vulnerabilities) and serious incidents under Regulation (EU) 2024/2847 on cyber resilience will be shared with the relevant national computer security incident response teams (“CSIRTs”) and the European Union Agency for Cybersecurity (ENISA). In addition, manufacturers will be required to report actively exploited vulnerabilities and serious incidents that do not qualify as serious incidents under the MDR or IVDR to the CSIRT and ENISA via Eudamed. In Annex I of the MDR/IVDR, cybersecurity will be explicitly mentioned in the general security and performance requirements [new Art. 87a and Annex I of the MDR; new Art. 82a and Annex I of the IVDR].

Expected consequences of changes

At this stage, it’s difficult to discuss the specific implications of the changes, as they are still in their early stages. The proposal for these changes has only just been submitted by the Commission, meaning the European Parliament will now have to adopt them. Nevertheless, this article will attempt to summarize and generalize the changes described above. The main changes can be divided into four categories: governance, innovation, digitization, and coordination.

Administrative changes will be most noticeable for manufacturers. Primarily, many periods will be extended (certificate duration, audit period, etc.) and the frequency of certain procedures (such as audits) will be reduced. Some formal requirements have been abolished, primarily for established technologies and orphan devices. Rules for certain risk categories will also change. Manufacturers will have more time to submit certain reports, and audits will now be possible remotely. Reductions in individual fees will be crucial for small and micro-sized manufacturers. A loophole is also planned for member states in emergency situations, when derogations from marketing authorization procedures will be possible.

In the innovation category, the changes primarily concern certain simplifications in the certification process for breakthrough technologies. Additionally, fewer approvals by notifying bodies will be required and access to certain data categories will be broader. The Commission also plans to prioritize greater expert involvement, at various levels. A key element is the possibility for the Commission or Member States to establish regulatory sandboxes, which will allow for greater flexibility and freedom in the development of new technologies.

In the area of digitalization, the changes aren’t groundbreaking, but they are definitely necessary given the current market realities. Much information will now be able to be transmitted digitally, and the Eudamed platform will gain greater importance.

The final category is coordination between authorities. A certain duplication of procedures has been observed, resulting in excessive administrative burdens. Some procedures have been eliminated or standardized (now, one application can replace others). Using digital platforms, authorities will share more information, reducing the burden on producers. Another step is to strengthen the MDR-appointed authorities and international cooperation.

Conclusion

While the changes seem promising for manufacturers, for whom many mechanisms are to be simplified, it is currently difficult to draw concrete consequences from the changes. They appear to be broad-based and positive, aimed at developing the opportunities of the medical devices market in the European Union, which already employs over 930,000 people. It is important to ensure a space where innovation can flourish while ensuring equal safety. Nevertheless, the changes were proposed in December, so it will be crucial to monitor the next stages and the European Parliament’s views on the changes.

Sources

European Commission, ‘Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonization legislation referred to in its Annex I’ [2025] COM(2025) 1023 final

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC [2017]

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU [2017]

European Commission, ‘New measures to make the EU health sector more innovative, competitive and resilient’ (European Commission, 2025) <https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077> accessed 26/01/2026

Artykuł Overview of the Commission’s proposed amendments to Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR) pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.