The medical device market in Poland is primarily regulated by EU regulations, which create a uniform system of requirements for safety, quality and supervision within the European Union. Two regulations of the European Parliament and of the Council are of key importance: Regulation (EU) 2017/745 (MDR) on medical devices and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices, which the Republic of Poland, as an EU member state, applies directly.

The above regulations are supplemented by national provisions on medical devices. With regard to specific aspects that are not regulated by the main act, implementing acts have been issued – regulations of the Minister of Health. In addition, medical devices are also subject to other national regulations, including provisions on reimbursement and medicinal products.

In practice, it is also necessary to monitor the announcements of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (hereinafter also referred to as the President of the Office) on a continuous basis in order to stay up to date with the supervisory authority’s interpretative positions.

Below is a detailed list of legal acts relating directly and indirectly to medical devices.

Legal Acts Directly Relating to Medical Devices

Legal acts directly regulating the manufacturing, placing on the market, making available, surveillance and advertising of medical devices are as follows.

• Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR) on medical devices.
• Regulation (EU) 2017/746 of the European Parliament and of the Council (IVDR) on in vitro diagnostic medical devices.
• Act of 7 April 2022 on medical devices – the main national act implementing and supplementing EU regulations, which defines, among other things, advertising rules, additional obligations for distributors, importers and users, as well as the competences of supervisory authorities and sanctions.
• Implementing regulations of the Minister of Health:
1. Regulation of the Minister of Health of 21 April 2023 on the advertising of medical devices;
2. Regulation of the Minister of Health of 26 July 2022 on fees for medical devices;
3. Regulation of the Minister of Health of 12 December 2022 on the template for reporting serious incidents; and
4. Regulation of the Minister of Finance of 2 December 2022 on compulsory insurance for sponsors and investigators in connection with the conduct of clinical trials of medical devices or performance studies of in vitro diagnostic medical devices,
• Act of 12 May 2011 on the reimbursement of medicinal products, foodstuffs for particular nutritional uses and medical devices – specifies the conditions under which medical devices are eligible for reimbursement from public funds, as well as restrictions on prices, margins and marketing activities related to medical devices reimbursed from public funds.
• Act of 6 September 2001 Pharmaceutical Law – applies to medical devices only to a limited extent, primarily in the context of trade in pharmacies and pharmacy outlets – ie, it specifies the rules under which medical devices may be sold in these establishments.
• Act of 11 March 2004 on Goods and Services Tax (VAT) – provides for the application of a reduced 8% VAT rate (instead of the standard 23%) on, inter alia, medical devices, in vitro diagnostic devices, accessory for a medical device, systems, procedure packs.

Legal Acts Relating to Other Product Groups That May Apply to Medical Devices

The following legal acts, although relating to other product groups, may also apply to medical devices:

• Act of 13 April 2016 on conformity assessment and market surveillance systems – refers to personal protective equipment to which the provisions of Regulation (EU) 2016/425 of the European Parliament and of the Council apply. The Act does not apply to medical devices, with the exception of pressure equipment and assemblies of pressure equipment, non-automatic weighing instruments and radio equipment,
• Act of 30 August 2002 on the conformity assessment system – the provisions of the Act apply to specific groups of medical devices, including machinery, aerosol products or electrical and electronic equipment in relation to the restriction of the use of certain substances.
• Act of 12 December 2003 on General Product Safety – a new act is currently being drafted to take into account the application of Regulation (EU) 2023/988 of the European Parliament and of the Council on general product safety.
• Act of 7 May 2009 on Prepackaged Goods.
• Act of 26 April 2024 on ensuring compliance with accessibility requirements for certain products and services by economic operators.

Legal Acts Indirectly Applicable to Medical Devices

The following legal acts, although not directly related to medical devices, are of significant importance for the economic activity of entities operating in this sector.

• Criminal Code – regulates, among other things, liability for causing bodily harm, exposing a person to immediate danger of death or serious bodily harm, document forgery, fraud, corruption, bribery and misleading others.
• Civil Code – regulates, among other things, warranty, contractual liability and liability in tort, quality guarantees, sales and delivery contracts.
• Commercial Companies Code – regulates the duties and liabilities of management boards of companies manufacturing, importing or distributing products.
• Act of 10 May 2018 on the protection of personal data – in the context of patient or user data collected by medical devices.
• Act of 23 August 2007 on Counteracting Unfair Market Practices.
• Act of 16 February 2007 on Competition and Consumer Protection.
• Act of 16 April 1993 on Combating Unfair Competition.
• Act of 11 September 2019 on Public Procurement Law.

Polish regulations do not provide for separate provisions for medical instruments.

Cosmetics

The basic sectoral regulations concerning cosmetics in Poland are primarily based on harmonised EU law. The key legal act is Regulation (EC) 1223/2009 on cosmetic products, which comprehensively regulates issues related to the safety, composition and surveillance of cosmetics. In addition, on 4 October 2018, the Polish legislature adopted the Act on Cosmetic Products, which supplements the provisions of the Regulation in areas left to be regulated at national level, resulting from the exclusive competence of member states, including the organisation and functioning of supervisory authorities, control procedures, the imposition of administrative sanctions and national requirements for reporting undesirable effects.

Biocides

This area is also subject to uniform EU regulations set out in Regulation (EU) No 528/2012 of 22 May 2012 concerning the placing on the market and use of biocidal products, which establishes a legal framework for the introduction and marketing of biocidal products on the European market. These are supplemented in Poland by the Act of 9 October 2015 on biocidal products.

Food and nutrition supplements

In Poland, food and nutrition supplements are primarily subject to harmonised EU law, which is supplemented by national provisions on notification, control and sanctions. At national level, the basic act is the Act of 25 August 2006 on food and nutrition safety, which implements EU regulations, specifies the procedure for notifying the Chief Sanitary Inspector of the first placing of a supplement on the market, the competence of the control authorities and the procedure for imposing sanctions. It is supplemented by regulations of the Minister of Health concerning, among other things, the list of permitted enriching substances, detailed composition requirements and notification templates to the supervisory authority.

Pharmaceuticals and Blood Products

The Act of 6 September 2001 – Pharmaceutical Law regulates the manufacture, import, placing on the market, marketing authorisation, advertising and surveillance of medicinal products.

The Act of 1 July 2005 on the collection, storage and transplantation of cells, tissues and organs sets out the rules for the procurement, storage, processing and use of cells, tissues and organs, including advanced therapy medicinal products. This Act also applies to stem cells.

The Act of 22 August 1997 on public blood services regulates the organisation of blood donation, the safety of blood and blood products, and the rules for their use.

The Reimbursement Act of 12 May 2011 on medicines, foodstuffs for particular nutritional uses and medical devices lays down the rules for financing medicines from the state budget under the health care system.

The Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use specifies in particular the procedure for granting authorisation for clinical trials, the rules and procedure for ethical evaluation of clinical trials, the obligations of the sponsor, principal investigator and investigator, and the rules on civil and criminal liability of the investigator and sponsor.

Of key importance in the medicinal products sector are the regulations of the Minister of Health, which specify, among other things, clinical trial procedures, requirements for registration documentation, details of marketing in pharmacies and wholesalers, as well as announcements by the Minister of Health concerning reimbursement rules, availability of medicines and information on drug programmes.

Psychedelics and Cannabidiol (CBD) When Used for Medicinal Purposes

The Act of 29 July 2005 on counteracting drug addiction is the main legal act regulating the status of controlled substances in Poland. The Act classifies these substances as narcotic drugs or psychotropic substances, depending on their properties and addictive potential. The Act introduces a general prohibition on the possession, manufacture, processing, import, export and placing on the market of these substances, providing for criminal sanctions for violations of the prohibition. Exceptions specified in the legislation are only permitted in strictly defined cases, such as approved scientific research, which requires a permit from the Chief Pharmaceutical Inspector.

In Poland, the use of medical cannabis is permitted under Article 33a of the Act on Counteracting Drug Addiction, according to which pharmaceutical raw material derived from non-fibrous hemp (Cannabis sativa L.) may be used for the preparation of prescription medicines, provided that it has been given marketing authorisation. This type of product is dispensed only on the basis of a medical prescription and is subject to control under the rules laid down in the Pharmaceutical Law.

On the other hand, products containing cannabidiol (CBD) come from fibre hemp, varieties of which are permitted for cultivation provided that the THC content in the dry matter does not exceed 0.3%. At this concentration, the product can be marketed without a prescription. The entire process is supervised by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, who authorises the raw material for use, and the Chief Pharmaceutical Inspector, who controls wholesale and retail trade.

Telemedicine

Polish law does not contain a single, precise definition of telemedicine. According to legal practice and case law, it is the provision of health services using Information and Communication Technology (ICT) or communication systems. Telemedicine in Poland operates on the basis of a number of regulations which explicitly allow for the provision of remote health services using ICT or communication systems. The legal basis is primarily provided by the Act of 15 April 2011 on medical activity, the Act of 5 December 1996 on the professions of physician and dentist, and the Act of 6 November 2008 on the rights of patients and the Commissioner for Patients’ Rights, which guarantee patients the same rights in telemedicine as in the case of in-person visits, including the right to information, informed consent and personal data protection.

Teleconsultation may include not only diagnosis and recommendations, but also the issuance of e-prescriptions, e-referrals or e-orders for medical devices. The rules for their implementation are laid down in the Act of 28 April 2011 on the health care information system and the implementing provisions of the Minister of Health.

An important element of the telemedicine system in Poland is the Internet Patient Account, which is a central tool for accessing e-health services, enabling, among other things, checking the history of issued and filled e-prescriptions, e-referrals, test results, history of visits financed by the National Health Fund, as well as downloading the EU COVID-19 Certificate. The Internet Patient Account operates within the P1 system, the rules of which are laid down in the Act of 28 April 2011 on the health care information system, the Act of 27 August 2004 on health care services financed from public funds, and the provisions on personal data protection. The Regulation of the Minister of Health of 12 August 2020 specifies the organisational standards for teleconsultations in primary healthcare, including the method of verifying the patient’s identity, documenting the visit and transmitting recommendations.

Medical apps and wearable devices are not subject to separate regulations in Poland. If they meet the definition of a medical device or medical device accessory, they are subject to the regulations referred to in 1.1 Medical Devices.

The problem of borderline products (medicines, medical devices, personal protective equipment, food, cosmetics, biocidal products) is quite common in Polish commercial practice, as in other EU member states. Their classification is based on the interpretation of definitions contained in individual legal acts, Court of Justice of the European Union (CJEU) rulings and recommendations developed by experts, in the case of medical devices by the Medical Device Coordination Group (MDCG). The application and proper legal classification of borderline products depend primarily on their use, composition and mechanism of action, which is why the product description and intended use declared by the manufacturer are of key importance.

Under Polish law, the Pharmaceutical Law lays down the principle of the primacy of pharmaceutical law in situations where a product meets the criteria for both a medicinal product and another type of product – eg, a supplement, cosmetic or medical device. This means that if a product meets the criteria of different categories regulated by separate provisions and at the same time can be classified as a medicinal product, the provisions of pharmaceutical law apply to it. This provision is crucial for borderline products, as it determines that the status of a “medicinal product” is overriding and determines how it is authorised for marketing. This avoids a situation where products with medicinal properties would be placed on the market under less restrictive legal regimes applicable to other categories.

Pursuant to the Medical Devices Act, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issues, at the request of the head of the customs and tax office, an opinion on whether a device, system or procedure pack meets the requirements specified for it. The President of the Office may also issue an opinion on whether a product on the market meets the definition of a device.

However, pursuant to the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the President of the Office is assisted by the Commission for Borderline Products, which deals with products that meet the criteria for both medicinal products and other types of products, and the Commission for Medical Devices, which deals with medical devices. The tasks of the Commission include issuing opinions on the classification of borderline products.

The design and manufacture of medical devices is carried out in accordance with the requirements of Regulations (EU) 2017/745 and (EU) 2017/746, taking into account all applicable implementing provisions and standards, including ISO 13485. In particular, the manufacturing process takes into account the requirements set out in Annexes I to both Regulations relating to the safety and performance of medical devices. In part, the provisions of the national Medical Devices Act also apply here.

Detailed Polish regulations refer in particular to the manufacture of medical devices in health institutions. The Minister responsible for health may restrict the production or use of certain products manufactured in these institutions if this is necessary to protect life, health or the safety of use of the products. Restrictions may include, among other things, conditions of production or use, the technical equipment required for the facilities and the qualifications of the personnel employed.

Under Polish law, the regeneration of single-use devices is permitted, but at the same time, the making available or further use of regenerated single-use devices is prohibited in the territory of the Republic of Poland.

Poland has no additional regulations concerning requirements for manufacturing sites or location requirements, in respect of the entity responsible for compliance requirements overall.

Poland has introduced regulations concerning corporate social responsibility, the environment and sustainable development, which may indirectly apply to the medical devices and health-related consumer products sectors.

With regard to obligations related to ensuring sustainable development throughout the product life cycle, it should be noted that Poland has implemented the provisions of Directive 2004/109/EC, Directive 2013/34/EU and Directive (EU) 2022/2464 of 14 December 2022 amending Regulation (EU) No 537/2014 as regards corporate reporting, including on sustainability. These directives have been implemented into the Polish legal system by amendments to the Accounting Act and the Act on statutory auditors, audit firms and public oversight. In particular, it is worth noting the latest Act of 9 July 2025 amending the Accounting Act, the Act on Statutory Auditors, Audit Firms and Public Supervision and certain other acts concerning the postponement of ESG reporting by two years, which concerns the disclosure by companies of information on, among other things, the impact of their activities on the environment, society and corporate governance.

Another legal act on environmental protection and the protection of human health and life, aimed at preventing waste generation, reducing its volume and minimising the negative impact of its generation and management, is the Act of 14 December 2012 on Waste. These provisions also cover the proper handling of medical waste, which includes, inter alia, used medical products and consumables such as syringes, needles, cannulas, dressings, gauze pads, plasters and medical gloves.

Healthcare service providers are required, inter alia, to register in the national database of products, packaging and waste management (BDO), keep records of medical waste, and segregate and store it in a manner that prevents exposure to potential infectious agents.

Due to the need to protect the environment, Polish law lays down specific rules for the handling of potentially infectious medical waste. These rules are set out in the Regulation of the Minister of Health of 5 October 2017 on the detailed procedure for the handling of medical waste.

The Act of 13 June 2013 on packaging and packaging waste management is also of significant importance in the area of medical device management and their impact on the environment. It sets out the requirements to be met by packaging placed on the market and the rules for handling packaging and packaging waste at all stages of the product life cycle, from manufacture and distribution to waste management.

Advertising in Polish Regulations

In its regulations on medical devices, the Polish legislature did not introduce a legal definition of the term “advertising”, which means that it has not been expressly defined in national legislation relating to medical devices. Consequently, in determining which activities fall within the scope of this term, it is necessary to refer to the literal and linguistic interpretation of the word. It is also necessary to take into account the views expressed in case law and legal doctrine, which provide certain guidelines for distinguishing elements that constitute advertising from those that constitute purely informational communication.

The Supreme Court has indicated that when distinguishing between information and advertising, it must be borne in mind that a statement constitutes advertising when the incentive to purchase the goods prevails over its informative content. This reflects both the intention of the sender and the perception of the average recipient to whom the message is addressed. In addition to the incentive factor, the second key element of advertising is the ability to identify the product. Therefore, a message will constitute advertising only if it is actually possible to identify a specific medical device. Thus, advertising of a medical device may be considered any activity relating to a specific device with the aim of encouraging recipients to purchase or use it.

The Polish Medical Devices Act provides a negative list of activities that do not constitute advertising within the meaning of the provisions. Thus, the following are not considered advertising of a device:

• commercial catalogues or price lists containing only the trade name, price of the device or technical specifications; and
• information placed on the packaging and attached to the packaging of products, required by the provisions of the Medical Devices Act and Regulation 2017/745 or Regulation 2017/746.

It should be emphasised that the above list is not exhaustive, which means that other activities not explicitly mentioned in the Medical Devices Act may also be classified as information, provided that they do not pursue a promotional purpose.

Advertising Directed to the General Public

Advertising directed to the general public includes messages addressed to the average recipient, in particular the patient. Such advertising includes not only advertising addressed to non-professionals, but also messages which, even contrary to the advertiser’s intentions, actually reach this group of recipients.

The Polish Medical Devices Act introduces a number of restrictions on advertising addressed to the general public. First of all, it requires that such advertising be formulated in a manner understandable to laypersons. It is also prohibited to use the image of persons practising in medical professions or claiming to be such persons, as well as to portray persons presenting the product in a way that may suggest that they are practising a medical profession.

In addition, advertising to the general public may not relate to products intended for use by users other than lay persons. It should be emphasised that, in accordance with the position of the surveillance authority, this prohibition covers products that can only be used by professionals. However, if a product can be used by both lay persons and professionals, its advertising in public communications is permissible.

Furthermore, advertising may not contain direct appeals to children encouraging them to purchase the product or to persuade their parents or other adults to purchase it.

It is also important that all advertising of medical devices intended for the general public must contain certain information required by law, in particular the details of the manufacturer, the authorised representative and the entity responsible for the advertising. In addition, it is necessary to include a warning stating: “This is a medical device. Use it in accordance with the Instruction for use or label”. The form of presentation of the warning depends on the type of advertising message.

Details concerning the publication of advertisements are specified in the Regulation of the Minister of Health of 21 April 2023 on the advertising of medical devices.

Marketing Activities Aimed at Professionals

The Medical Devices Act does not explicitly specify which entities should be considered professionals. Based on the wording of the Medical Devices Act and pharmaceutical law, it can be concluded that advertising directed at professionals may be addressed in particular to persons practising a medical profession and persons trading in medical devices.

Those wishing to advertise exclusively to professionals must take appropriate measures to ensure that their advertising does not reach the general public. This issue is most problematic in the case of advertising via the internet. Therefore, when deciding to advertise to professionals in this form (website, social media), appropriate injunctive relief should be sought.

Other Important Issues in the Field of Medical Device Law

The Polish Medical Devices Act stipulates that advertising of a device may only be conducted by economic operators, including manufacturers, importers and distributors of medical devices. Advertising of a device may also be conducted by other entities, but only after written approval by the economic operator concerned.

However, digital advertising on the internet, including on Google and Meta platforms, and advertising by influencers, which are not explicitly regulated in the medical device law, raise many doubts. In the case of the latter, it is necessary to carry out additional verification of messages under the provisions on combating unfair competition and competition and consumer protection law.

Other Legal Regulations Applicable to the Advertising of Medical Devices

Pursuant to the Pharmaceutical Law Act, it is prohibited to advertise non-pharmacy outlets and their activities relating to medicinal products or medical devices, where non-pharmacy outlets are defined as herbal medicine shops, specialist medical supply shops and shops open to the general public. In practice, this means restrictions on advertising at points of sale, such as general stores, petrol stations and shopping centres, if the advertising includes or refers to medical devices.

According to the Act on Combating Unfair Competition, unfair competition includes, in particular, advertising that is contrary to the law, good morals or human dignity, misleading to the client, appealing to emotions by causing fear, as well as advertising that significantly interferes with privacy – eg, through intrusive solicitation in public places or abuse of technical means of communication. Comparative advertising – ie, advertising that enables direct or indirect recognition of a competitor or their goods or services, is also considered an act of unfair competition if it is contrary to good morals.

Misleading market practices under the Act on Counteracting Unfair Market Practices include, among others:

• using a certificate, quality mark or equivalent sign without being entitled to do so;
• bait advertising, which consists in offering a product at a specified price without disclosing that the trader has reasonable grounds to believe that it will not be able to supply the product or order equivalent products from another trader;
• claiming that a product will only be available for a very limited time or that it will be available on specific terms for a very limited time, if this is not true; and
• surreptitious advertising, which consists of using editorial content in mass media to promote a product, where the trader has paid for the promotion and this is not clearly apparent from the content or from images or sounds that are easily recognisable by the consumer.

Special regulations apply to medical devices financed or co-financed from public funds. The Reimbursement Act for medicines, foodstuffs for particular nutritional uses and medical devices provides for sanctions for unlawful activities aimed at increasing the sale of reimbursable products. For example, it is prohibited to offer conditional sales, discounts, rebates, packages and loyalty programmes, donations, prizes, trips, games of chance, mutual betting, various types of vouchers and coupons, as well as to grant other financial or personal benefits to beneficiaries and proprietors.

Under Polish law, trading in medical devices does not require a licence, permit or entry in the register of regulated activities authorising trading in medical devices. Unlike medicinal products, which may only be sold wholesale by pharmaceutical wholesalers, trading in medical devices does not require entities to have the status of a pharmaceutical wholesaler. In the case of reimbursable medical devices, this issue raises doubts and discussions are currently underway regarding changes in the law (more in the Trends & Developments chapter in this guide).

As a rule, products placed on the Polish market must meet the requirements of the regulations on medical devices. One of the key exceptions provided for in Polish law is the possibility of placing on the market or putting into service a product that has not undergone a full conformity assessment procedure. This applies to special situations where public health interests or the need to protect the life and safety of patients so require. In such cases, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may authorise the placing on the market or use of the product. An application for such authorisation may be submitted by, among others, entities providing healthcare services, national consultants, the President of the Agency for Health Technology Assessment and Tariff System, the President of the National Health Fund or the President of the Government Agency for Strategic Reserves.

In addition, Polish regulations on medical devices provide for a number of prohibitions aimed at protecting public health and ensuring the safety of patients and users. These include:

• it is prohibited to place on the market, distribute or use a medical device whose expiry date specified by the manufacturer has passed, whose safe period of use has been exceeded or whose number of possible cycles of use has been exhausted;
• it is prohibited to place on the market devices, systems or procedure packs for which the certificates of conformity have expired, been withdrawn or suspended; and
• it is unacceptable to supply lay persons, for their own use, with diagnostic devices other than those intended for self-testing, sample containers or laboratory products for general use.

In the event of a breach of the above prohibitions, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may issue an administrative decision to withdraw from the market or use products introduced, distributed, made available or used in violation of the provisions, if required by public health protection or patient safety.

Under Polish law, medical devices may not be sold by means of an agreement concluded outside the business premises within the meaning of the Act of 30 May 2014 on consumer rights. An exception is when the agreement is concluded during a visit to the consumer’s home or place of residence, provided that it was made at the consumer’s express invitation. A distinction should be made between off-premises sales and distance sales, which are not subject to such restrictions.

With regard to medical devices used in the territory of the Republic of Poland, detailed national regulations apply concerning the language in which information must be provided and documents drawn up. These are intended to ensure full transparency of data for patients, users and surveillance authorities, and thus the safe and correct use of devices.

In accordance with the Medical Devices Act, a device intended for lay users must have labels, a user’s guide and a user interface in Polish (possibly using harmonised symbols or recognisable codes) and a declaration of conformity in Polish or translated into Polish. As an exception, the interface may be in English – with the exception of devices for use in life-threatening situations – provided that all commands and terms are explained in the instructions, this does not pose a risk to the user, and this fact is clearly indicated on the packaging.

The situation is different for products intended for professional users. In this case, labels, instructions and declarations of conformity may be in Polish or English, but only information directly addressed to the patient must remain in Polish or be presented using harmonised symbols or codes.

Within the EU single market, the main driver of expansion is the harmonisation of legal regulations resulting from the application of MDR/IVDR and technical requirements resulting from the implementation of harmonised standards by the Polish Committee for Standardisation (PKN). Compliance with these regulations opens up access to the European Economic Community, which by definition reduces barriers to entry between EU member states and facilitates the movement of products between jurisdictions within the EU.

In addition, the President of the Office – on the basis of Regulations (EU) 2017/745 and (EU) 2017/746 and the Act on Medical Devices – issues Free Sale Certificates confirming that a product bearing the CE mark can be legally marketed in the EU and is primarily intended for export. In Poland, the FSC is issued within 15 working days of the submission of the application, for a fee of PLN700 (approximately EUR165). In 2024, the President of the Office received 863 applications and issued 757 certificates, which shows that this instrument is widely used for expansion into non-EU markets.

In the Polish context, the decision to expand abroad is influenced by many factors, including the scale of operations, raw material prices, production and labour costs, the level of taxation and the availability of subsidy programmes. In highly regulated sectors, such as medicinal products and medical devices, entities planning global sales must in any case meet full compliance requirements and be subject to surveillance. However, additional difficulties arise from formal national requirements in target markets and divergent approaches by regulators to the qualification and classification of products and borderline products, which often prolong the market entry process and increase its costs.

Notifications to Regulatory Authorities

The previous registration system, established by the previous Medical Devices Act of 2010, was based on submission made by manufacturers and authorised representatives and on notifications made by importers and distributors. Under transitional provisions, these entities (with the exception of distributors) may still fulfil their registration obligations under the “old” rules, but once they have registered in the Eudemed database, they are exempt from national procedures.

At the same time, the Medical Devices Act of 2022 introduced new, fully electronic registers kept by the President of the Office. These include:

• a list of distributors of devices, systems or treatment sets based in the territory of the Republic of Poland (for distributors which have brought devices into the territory of Poland);
• a system collecting information on medical devices, systems and procedure packs brought into the territory of the Republic of Poland by entities and persons performing medical activities and other entities using medical devices for business or professional activities; and
• a register of manufacturers of custom-made products, authorised representatives of manufacturers of custom-made products not established in an EU member state and importers of custom-made products.

Registration in these systems is free of charge.

Post-Market Surveillance Obligations

The main post-market surveillance obligations arise from the MDR and IVDR, while the Polish Act specifies the national path for reporting medical incidents.

Any person may report a serious incident that has occurred in Poland to the President of the Office. However, the obligation to report immediately a serious incident or, where applicable, to report a suspected serious incident to the manufacturer or its authorised representative lies in particular with entities and persons using the devices professionally, as well as importers, distributors, testing laboratories, institutes, entities servicing and calibrating devices, and entities conducting external quality assessment of diagnostic laboratories. A copy of the report shall be forwarded in parallel to the President of the Office. The notifier shall be obliged to provide the manufacturer, their authorised representative and the President of the Office with the necessary assistance in the investigation, including providing information and making the device and products used in combination with it available for testing.

Safety notes shall be published by the President of the Office, where justified by the need to protect public health, in the Public Information Bulletin on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

The President of the Office has extensive supervisory powers over entities operating on the market, including control of compliance with requirements after the products have been placed on the market. The scope of these powers is described in detail in 3. Regulator Engagement and Enforcement.

The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is the central government administration body responsible for matters related to:

• marketing authorisation for medicinal products, with the exception of medicinal products authorised for marketing without a marketing authorisation;
• making available on the market and use of biocidal products;
• clinical trials, including veterinary clinical trials;
• medical devices, accessories for a medical device, systems and procedure packs, products not intended for medical use, including their clinical trials, safety and placing on the market and into service, as well as their surveillance; and
• in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices, including their performance testing, safety and placing on the market and into service, and surveillance thereof.

The State Pharmaceutical Inspection, in order to protect the public interest in the safety of human health and life in the use of medicinal products and medical devices in pharmaceutical wholesalers, pharmacies, hospital pharmacy departments, pharmacy outlets and non-pharmacy outlets, exercises surveillance over, inter alia:

• the conditions for the manufacture and import of medicinal products and veterinary medicinal products;
• the conditions for the manufacture, import and distribution of active substances;
• the quality, marketing and intermediation in the marketing of medicinal products, with the exception of veterinary medicinal products; and
• the marketing of medical devices, with the exception of medical devices used in veterinary medicine.

The State Sanitary Inspection is established to perform tasks in the field of public health in order to protect human health against adverse environmental effects and nuisances, prevent the occurrence of diseases, including infectious and occupational diseases, in particular by exercising surveillance over the conditions of:

• environmental hygiene;
• radiation hygiene;
• health of food, nutrition and cosmetic products; and
• hygiene and sanitary conditions to be met by medical personnel, equipment and premises where health services are provided.

The tasks of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products include surveillance of medical devices and their safety. The detailed powers of the President of the Office in relation to medical devices are specified in the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Act on Medical Devices. According to these acts, the President of the Office plays a key role in the medical device surveillance system. They have key competences, which include issuing administrative decisions on prohibiting or restricting the availability of a device, its withdrawal from the market or from use. In the event of a breach of the provisions on the advertising of medical devices, they order the removal of the identified infringements, the cessation of the publication, display or advertising of the advertisement in question, or the publication of the decision in places or media of mass communication.

Persons authorised by the President of the Office to carry out inspections have a wide range of powers to effectively detect non-compliance and gather evidence. They may visit any premises, sites and means of transport used by the inspected entity, as well as its suppliers and subcontractors. These powers also include the right to request oral or written explanations, to inspect documents and other information carriers, and to access data relevant to the subject of the inspection. Inspectors have the right to examine documents, products and equipment, take samples of products for testing and verify the implementation of post-inspection recommendations.

The tasks of pharmaceutical inspection in the area of medical devices include, in particular, control of the conditions of transport, handling and storage of products, surveillance of pharmacies and other entities engaged in the wholesale and retail trade in medicinal products and medical devices, as well as control of the correct labelling and advertising of medicinal products and the labelling of medical devices.

The consequences of violating safety rules in the trade of medical devices are reflected in administrative penalties. Such violations include, for example, failure by entities in the supply chain to comply with the requirements laid down in Regulations (EU) 2017/745 and (EU) 2017/746, failure by the manufacturer to establish a risk management system, and failure to comply with information obligations towards surveillance authorities. An important measure for enforcing the regulations is the establishment of a system of administrative fines. These fines can be as high as PLN5 million (approximately EUR1,178,000). The amount of the penalties is a preventive measure and serves as a disciplinary measure for entities involved in the medical device supply chain.

The Polish legislature has also provided for administrative penalties for violations of the rules on advertising medical devices. The ratio legis of this solution is primarily to ensure the safety of users, as incorrect information provided in advertising may lead to the misuse of a device and, consequently, pose a threat to life or health. For this reason, advertising that misleads as to the device’s intended purpose, safety or performance of a product is subject to a penalty of up to PLN5 million (approximately EUR1,178,000), while other violations of advertising rules may be punished with fines of up to PLN2 million (approximately EUR,471,000).

Pharmaceutical law provides for sanctions not only in the form of administrative fines of up to PLN5 million (approximately EUR1,178,000) or in the form of immobilisation of the place of manufacturing or import, pharmaceutical warehouse, pharmacy, pharmacy outlet or other facility, or withdrawal of a medicinal product or medical device from the market, but also criminal sanctions in the form of fines, restriction of liberty or imprisonment for up to five years.

Although the MDR and IVDR regulations have been in force for some time, in practice the process of adapting to their detailed requirements is still ongoing. This is due both to the large number and complexity of the regulations and to the need to change the existing practices of market operators. At this stage, however, most administrative proceedings do not concern direct breaches of safety rules by the devices themselves but focus on formal issues such as the incorrect choice of clinical trial procedure, irregularities in documentation, misleading or unlawful advertising practices.

Experience to date shows that when imposing administrative penalties, the President of the Office often mitigates them, making the amount of the penalty dependent on several factors, in particular the number and nature of the infringements, their seriousness, and the scale and importance of the economic operator’s business. The aim is to ensure that the penalty remains proportionate to the degree of the infringement and the real economic capacity of the entrepreneur.

Under the rules laid down in the Medical Devices Act, the President of the Office may also waive the imposition of a penalty. This applies to situations where the event was incidental, did not pose a risk, and the entity remedied the infringement within the time limit set by the President and informed the authority thereof. In practice, however, waivers of penalties are rare.

With regard to claims for damages, the provisions of the Civil Code governing liability for damage caused by a defective product, adopted as part of the implementation of Council Directive 85/374/EEC, are of key importance. The liability regulated by these provisions is based on the principle of risk – ie, it is independent of any fault on the part of the liable party. In a dispute with the liable party, the injured party must therefore prove the occurrence of damage, the defective nature of the product and the causal link between the defective product and the damage.

Medical devices may be classified as defective if they do not provide the expected safety when used normally. Importantly, such “defectiveness” of a product may result not only from its composition or design, but also from its presentation on the market and the information provided to consumers, such as instructions for use or a leaflet. It cannot be ruled out that damage may occur as a result of an error on the part of the injured party, which of course excludes the attribution of liability to other entities.

The manufacturer (including the manufacturer of the material or parts of the product) is primarily liable for damage caused by a defective product. Entities claiming to be the manufacturer (eg, distributors) and importers are also liable in the same way as the manufacturer. Under medical device law, entities that make available a device under its name or registered trade mark, change the intended purpose of a device or modify a device already placed on the market, may be liable. Any other persons who, through their actions or omissions in connection with the product, have caused damage (eg, medical personnel or pharmacies) may also be held liable.

It is worth noting that the provisions of the MDR and IVDR impose an obligation on medical device manufacturers to take out insurance against potential liability under EU regulations on liability for defective products.

The provisions on liability for damage caused by a defective product do not exclude liability under other titles, so the injured party may consider seeking compensation on general grounds (ex contractu and ex delicto). Product defects may also give rise to claims under, among other things, the manufacturer’s warranty for defects or guarantee.

The EU legislature’s response to technological progress and the resulting need to adapt the nearly 40-year-old rules on liability for defective products is the adoption of Directive 2024/2853 of the European Parliament and of the Council. With regard to technological developments, the new directive provides, among other things, for the inclusion of digital manufacturing files and software in the definition of “product” and the obligation to take cybersecurity requirements into account when assessing product defects. The new provisions must be implemented into national law by 9 December 2026, so legislative work on amending the relevant provisions of the Civil Code can be expected in the near future.

Pursuing claims in court requires the injured party to file a lawsuit. The lawsuit must meet the formal requirements specified in procedural regulations, including, among other things, indicating the date on which the claim became due and the facts on which the claimant bases their claim.

Compensation cases (as property rights cases) are heard in the first instance by regional or district courts (if the value of the dispute exceeds PLN100,000 – approximately EUR20,000). An appeal against a first instance court judgment may be lodged with the district court or the court of appeal, as appropriate. A final judgment of the court of second instance may be appealed to the Supreme Court. However, a cassation appeal is not admissible if the value of the subject matter of the appeal is less than PLN50,000 (approximately EUR12,500) and is not based on allegations concerning the determination of facts or the assessment of evidence.

When initiating a civil trial, the claimant should, as a rule, pay a court fee. In the case of monetary claims, the amount of the fee depends on the amount claimed. However, it is possible to exempt a person in a difficult financial situation from court costs.

As a rule, the winning party is entitled to a refund of the costs of the trial. In exceptional circumstances, however, the court may order the losing party to pay only part of the costs or not to pay any costs at all. A partial success in a civil case leads to the mutual waiver or proportional allocation of costs. In the event of a court settlement or a court-approved settlement reached before a mediator, the parties bear the costs of the proceedings in equal parts (unless otherwise agreed in the settlement), and the claimant is entitled to a refund of half of the court fees paid.

In the case of a party represented by a professional representative, the costs of the proceedings consist of the costs of legal representation, court costs and the costs of compulsory appearance in court. The costs of legal representation are determined on the basis of minimum rates specified in a separate legal act, which depend on the value of the subject matter of the case or are assigned to a specific type of case. If a civil case requires a hearing, the civil court, taking into account the amount of work performed by the representative and the nature of the case, may set the costs of legal representation at up to six times the minimum rate.

In the event of an unfavourable decision by the national regulatory authority – the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (eg, prohibition of marketing or withdrawal from the market), the party may file an appeal in the form of a request for reconsideration of the case. The deadline for submitting such a request is 14 days from the date of delivery of the decision to the party in the first instance. The effective submission of a request for reconsideration suspends the execution of the contested decision, unless it is subject to immediate enforcement by law or on the basis of the order imposed by the first instance authority.

The model of judicial review of public administration in Poland gives the party the possibility to file a complaint against administrative decisions to an administrative court, which examines only the legality of the contested decision. The deadline for filing a complaint is 30 days from the date of delivery of the decision to the party. Unlike a request for reconsideration of a case, the suspension of the execution of a decision does not take effect upon the filing of a complaint with the administrative court. However, if the party is at risk of significant damage or irreversible consequences as a result of the enforcement of the decision, it should request that the enforcement of the decision be suspended. The party may appeal against the judgment of the administrative court to the Supreme Administrative Court.

The actions of entities operating on the medical device market, such as breaching the obligation to provide accurate information or acts of unfair competition, may also be classified as practices infringing the collective interests of consumers. In such a case, the national competition authority may issue a decision ordering the cessation of a specific practice. In this case, we also use the administrative appeal procedure.

In cases concerning liability for damage caused by a defective product, it is possible to bring a class action based on the Act on the Pursuit of Claims in Group Proceedings. The provisions on group proceedings apply when at least ten persons pursue claims of the same type based on the same factual basis or claims with common relevant factual circumstances. If monetary claims are being pursued, the amount of the claims of individual members of the group or of a subgroup (consisting of at least two persons) should be standardised. For a case to be heard in group proceedings, an appropriate request must be made in the lawsuit.

In order to be a member of a group acting as a claimant in group proceedings, the injured parties must submit a statement of accession to the group and agree on a representative of the group. However, the injured parties are not obliged to join the group and may pursue their claims individually.

Class action proceedings differ from ordinary civil proceedings in several important ways, including the jurisdiction of the court (cases in the first instance are heard by the district court regardless of the value of the claim) and the requirement for representation by a professional attorney.

In addition to class actions, there are also other mechanisms enabling the joint examination of several cases related to liability for a defective product, such as the combination of related cases for joint examination or formal participation on the part of the injured parties.

With regard to medical devices, class actions have not yet been used in practice by Polish courts.

Recognising the benefits for the justice system of out-of-court settlement of civil disputes, the legislature has provided for a number of legal mechanisms to encourage parties to ADR.

Before filing a lawsuit, the claimant should attempt to settle the dispute amicably. If no such attempt has been made, the claimant must explain the reasons for this in the lawsuit. In the course of the proceedings, the court should seek to settle the case amicably, which may take the form of a settlement reached before the court, a settlement reached before a mediator, or an out-of-court settlement.

In contractual relations, the parties may also include additional clauses related to ADR, such as a clause referring the dispute to arbitration (arbitration court) or a clause on out-of-court settlement of disputes arising from the contract.

Criminal, civil and administrative liability mechanisms are independent of each other in the sense that the absence of liability of one type does not automatically imply liability of another type. In particular, obtaining compensation or damages in criminal proceedings does not preclude the pursuit of the remaining part in civil proceedings. However, decisions made under individual mechanisms may influence the attribution of another type of liability. For example, a civil court is, as a rule, bound by the findings of a final criminal ruling regarding the commission of a crime.

The field of life sciences is increasingly becoming a topic of discussion in Polish politics. More legislative measures, development strategies, projects and discussions concern scientific research related to innovations in medicine, including their safety and impact on the environment. Polish authorities and state agencies are actively shaping policy in relation to the functioning of the medical devices sector.

In February 2025, the Council of Ministers adopted a regulation establishing the IDEAS Research Institute. The Institute’s activities include conducting scientific research and development work in the field of exact sciences.

At the same time, the following entities are actively involved.

• National Centre for Research and Development (NCBR), which is a key centre for supporting and creating innovative technological and social solutions. Among other things, it supports the development of technologies and solutions, including those related to the environment.
• The Medical Research Agency (ABM) is a state agency responsible for the development of research in the field of medical and health sciences. Its objective is to build an innovative healthcare system. The agency organises competitions, among other things, for entrepreneurs, for research in the field of medicine safety, innovative therapies and medicines of the future.
• The Polish Agency for Enterprise Development (PARP), whose objective is to implement economic development programmes supporting innovative and research activities of small and medium-sized enterprises, regional development and the use of new technologies in business. The agency has carried out projects such as “Environmentally Friendly Technologies” and “Investments in the Implementation of Environmental Technologies” and promotes solutions supporting corporate social responsibility.

In addition, initiatives such as the Green Coalition for Health are emerging in the country, providing a platform for co-operation for the sustainable development of the healthcare sector in Poland. The task of the Green Coalition for Health is to disseminate and promote sustainable development models, work to minimise negative environmental impacts, prevent the health effects of environmental hazards and improve the quality of sustainable management in the healthcare sector. In April 2025, the Coalition published a comprehensive report entitled “Medical devices from an economic and ecological perspective”.

Legislative work is currently underway to amend the Act on Reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices, known as the Broad Amendment to the Reimbursement Act (Szeroka Nowelizacja Ustawy Refundacyjnej – SZNUR). This will be the second amendment to the Reimbursement Act in recent years, which aims, among other things, to facilitate access to medicines and medical devices, simplify procedures and correct errors in the previous amendment.

SZNUR provides for a number of legislative changes relating to the reimbursement of medical devices available in pharmacies on prescription (eg, certain dressings, glucose meter strips). The changes in this area are common to medical devices, medicinal products and foodstuffs for special nutritional purposes and concern, among other things, the waiver of the requirement to demonstrate the availability of a medical device on the date of submission of the reimbursement application, the possibility of changing the addressee of the reimbursement decision, and obligations regarding the volume and continuity of supplies.

With regard to medical devices issued to patients on the basis of a separate order (eg, orthoses, prostheses, hearing aids, wheelchairs), SZNUR provides for the introduction of an obligation to review medical devices reimbursed under this procedure at least once every two years, in order to enable comprehensive adaptation of the catalogue of reimbursed devices to the needs of patients and market realities, taking into account the growing social demand for these products and the development of medical technologies.

The key legal act regulating artificial intelligence is the AI Act – ie, Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828. The Regulation entered into force on 1 August 2024 and will be fully applicable from 2 August 2026.

Regulations on artificial intelligence, in particular the AI Act, have a significant impact on the functioning of the medical device market. The AI Act indicates that more than one piece of Union harmonisation legislation may apply to a single product, such as Regulation (EU) 2017/745 or Regulation (EU) 2017/746, since making a product available or putting it into service may only take place if the product complies with all applicable EU harmonisation legislation. However, it should be noted that the AI Act and the MDR/IVDR have separate risk criteria and conformity assessment procedures. The risk classification under the AI Act applies to the AI system as such, and not necessarily to the entire product in which the system is used.

At the national level, work is underway on the Artificial Intelligence Systems Act. The Act is intended to be of an executive and implementing nature, with its main objective being to establish an organisational framework for the enforcement of the AI Act. The draft of this Act was updated in 2025, introducing, among other things, changes to the supervision of the AI market as well as to support for innovation and testing of new technologies. The draft provides for the establishment of the Artificial Intelligence Development and Security Commission, which would act as the market surveillance authority for artificial intelligence systems. It will operate a national contact point through which citizens and entities will be able to report infringements of the AI Act. The Commission would co-operate, among others, with the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in matters relating to the use of artificial intelligence systems in medical devices, medical diagnostics, disease treatment, and in connection with the manufacture, testing or use of medicines. The draft provides that the Commission will include, among others, a representative of the President of the Office.