Applicable Laws

As a member of the European Union, Poland directly applies Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). The aspects of the EU regulations that were left to members states’ discretion are the subject matter of the Polish Act on Medical Devices of 7 April 2022, which entered into force on 26 May 2022. The said Act also establishes the jurisdiction of the Polish competent authority, extensive financial sanctions as well as far-reaching advertisement regulation.

Personal Protection Equipment (PPE) is regulated by EU Regulation 2016/425 on personal protective equipment. There is no product-specific Polish regulation in this respect; however, issues related to market surveillance, sanctions or manufacturing are partially covered by the Polish Act on Conformity Assessment Systems and Market Surveillance of 13 April 2016.

Additional regulatory regimes affecting the sale and marketing of medical devices

Some legal regulations significantly affect the sale and marketing of medical devices in Poland, ie:

• the Act on Reimbursement of Medicinal Products, Special Purpose Foodstuff and Medical Devices (the “Reimbursement Act”) – stipulates conditions under which medical devices are subject to reimbursement from public funds and limits on prices, margins as well as certain marketing activities relating to publicly reimbursed medical devices;
• the Pharmaceutical Act – bans advertising of retail points of sales if advertisement refers to a medical device;
• the VAT Act – establishes a reduced 8% VAT rate (as opposed to the standard 23% rate) for medical devices, accessories, procedure packs, systems, in vitro diagnostic (IVD) and IVD accessories, as well as for repair and maintenance services;
• Criminal Code - sets out anti-bribery laws and penalises acts against the interests of public procurers;
• Public Procurement Act - transposes EU procurement directives into Polish law;
• executive ordinances enacted by the Minister for Health – establish a complex system of healthcare services financed publicly and in certain situations provide for minimum availability requirements related to medical devices; and
• by-laws created by the President of the National Health Fund – enhance and expand the system of ordinances enacted by the Minister for Health and provide for the legal basis of financing healthcare services, including services rendered using medical devices.

Healthcare products other than medical devices are subject to different legal regulations at the EU level. These regulations are transposed into Polish law, in particular:

• cosmetics – the Act on cosmetic products of 2018;
• biocides – the Act on biocides of 2015;
• food (including GMO, novel food, etc) – the Act on safety of food and nutrition of 2006.

The development, production, trade and advertising of medicinal products fall under the Polish Pharmaceutical Act, transposing all relevant EU pharmaceutical directives and regulations.

Tissue and cell products are regulated by the Act on the collection, storage and transplantation of cells, tissues and organs of 2005. Blood and plasma is covered by the Act on public blood service of 1997.

From a legal perspective, all medical applications and wearables – ie, IT products aiding in diagnostics, rehabilitation, or patient treatment, are considered medical devices in their own right. There is no separate Polish legal act on digital health products or telemedicine, except for the executive ordinance of the Minister for Health on the organisational standard of teleconsultation within primary healthcare. This legislation permits physicians to remotely consult patients using IT-enabled audiovisual systems.

Issues concerning product classification – whether as medical devices, medicinal products, PPE, etc – are frequent in Polish commercial practice. Debates over a product’s legal status mirror the EU standard, often referencing existing precedents and guidelines like those by the Medical Device Coordination Group (MDCG).

In many EU nations, the competent authorities tend to adopt an “inclusive” approach: when in doubt, they often apply medical device regulations to borderline products to prioritise patient safety. However, in Poland, for many years the VAT rate for medical devices was lower than the rate established in EU law (although this is no longer the case due to changes in EU VAT laws), the Polish competent authority employed an “exclusive” approach. This stance led to numerous administrative court cases where businesses contested the denial of their product’s medical device status. Despite the fact that national VAT rates are now aligned with EU law, this “exclusive” approach seems to persist.

This “exclusive” approach also extends to customs and tax authorities. They often scrutinise borderline products, initiating legal proceedings to determine custom duties, applicable VAT, or the legality of trading such products. The Polish competent authority is granted legal power to provide other authorities with opinions on the legal status of products – ie, whether or not they should be classified as medical devices. Although these opinions are not binding on customs or tax authorities, in most cases, they are followed and final decisions may only be challenged before the administrative court.

The main factors triggering borderline classification proceedings are: (i) importing products through Polish customs and (ii) complaints lodged by competitors.

Noteworthy classification cases include controversies over the legal status of anti-allergy bedding, hearing devices (not hearing aids), hyaluronan-based solutions, vaginal suppositories (with no pharmacological substances), allergy test kits, and medical scrub suits.

The design and manufacture of medical devices are subject to MDR/IVDR requirements. The market practice is similar to other EU countries. However, the Polish Act on Medical Devices requires that if products are sold to lay persons (patients), external packaging, instructions and the product interface must be made available in Polish. If the interface is in English, the law requires that all functions be translated into Polish in a written instruction and the external label bears an additional special warning, informing buyers that the interface is not in Polish. If the product is made available to professionals (medical doctors, other professionals, medical facilities), the product instructions, label and interface can be in English. Language requirements pertain to products that are placed on the Polish market and do not extend to the wholesale phase – eg, if the products are destined for other markets or are in transit.

No specific Polish laws are applicable in this respect. The market practice is similar to other EU countries.

Polish law provides for a complex regulatory framework relating to advertising and promoting medical devices. This framework differs significantly from laws and practices in other EU states and must be always taken into consideration before accessing the Polish market or launching marketing campaigns directed to Polish customers.

Advertising Regulation in the Act on Medical Devices

In July 2023, the Polish Act on Medical Devices introduced stringent advertising regulations for medical devices. These provisions set out many burdensome obligations on the part of advertisers and the maximum non-compliance penalties are approximately EUR450,000.

Key provisions include:

• a ban on advertising medical devices intended for professional use only to the general public (eg, hyaluronic acids, CTs, MRIs, USG machines, lasers, implants);
• a ban on using images of healthcare professionals in advertising targeting the general public;
• a ban on advertising medical devices by entities other than producers, ARs (authorised representatives), importers or distributors, unless written consent is provided;
• an obligation to provide oral and/or written warnings in advertisement targeting the general public (similar to warnings applied with regard to medicinal products); and
• an obligation to store advertisement blueprints and make them available to authorities at their request.

The ban on advertising medical devices intended for professional use only to the general public is widely perceived as a major impediment and causes considerable marketing problems, especially since certain devices (dental implants, beauty medicine products, orthopedic solutions) are advertised directly to patients, despite the fact that they are prescribed or applied by medical doctors or other healthcare professionals.

To address ambiguities in the interpretation of this ban, guidelines were formulated by Fairfield lawyers, in collaboration with the Polmed Trade Association and the Polish Competent Authority (URPL). These guidelines clarify:

• whether a medical device is intended for use by healthcare professionals only will clearly follow from the conditions of use (instructions and/or labels) provided by the producer;
• if a product is usable by both patients and healthcare professionals (eg, wound dressing), the ban is not applicable;
• purely informative texts and educational activities are exempt;
• web-based activities limited to sales on marketplaces, sales websites etc, are not covered by the ban, unless the content exceeds the information necessary to facilitate a sale;
• websites that are not publicly accessible are exempt from this ban (a clear pop-up warning is deemed sufficient in this respect);
• the prohibition does not extend to promoting general technology, unless an individual medical device is the object of the communication; and
• information disseminated for business communication purposes (growth of sales, merger, new product launch, market share, etc) is not covered by the ban.

The ban casts doubts over widespread yet controversial market strategies that leverage close collaborations with bloggers and influencers. When an influencer’s content (such as a podcast) functions as an advertisement for a medical device intended for professional use, the influencer risks facing administrative financial penalties. There could also be possible legal implications if it emerges that a market player is orchestrating the content creation.

Digital marketing practices, especially on platforms like Google Ads, TikTok, and Instagram Reels, also fall within this grey area. Typically, the challenges revolve around adhering to technical requirements, such as fitting necessary warnings within the constrained spaces provided by these platforms. To navigate these ambiguities, Fairfield, in collaboration with the Polmed Trade Association, has issued market guidelines, which can be accessed here. These guidelines outline potential strategies businesses can adopt to ensure compliant marketing activities, given the uncertainties in the legislation.

The new law does not stipulate rules on the maximum value of promotional gifts or the frequency and maximum value of product samples. Many firms apply the norms laid out in the Pharmaceutical Act, deeming PLN100 (approximately EUR23) as the maximum permissible value. However, some businesses opt for a less stringent cap of PLN200 (approximately EUR46). Distributing samples is generally seen as permissible. But the distribution’s frequency, volume, and value must be within reasonable limits, informed by the product’s value, promotional objectives, educational merit, and the recipient (patient/nurse/individual medical doctor/medical facility owner).

Advertising Regulation in the Pharmaceutical Act

Advertising of retail points of sale, such as general stores, pharmacies, gas stations, and trade centres, which include or are related to specific medical devices, is prohibited under the Pharmaceutical Act. Violators risk a fine of approximately EUR12,000. Introduced in 2012, this regulation was designed to safeguard the interests of pharmacies, particularly since a total advertising ban for pharmacies was enacted in the same year.

Promotion Restrictions Set Out in the Reimbursement Act

For medical devices financed or co-financed by public funds, additional legislative provisions apply. Notably, there is a ban on offering material incentives of any kind to both patients and prescribers.

While the legal wording is ambiguous, the consensus among legal experts is that this prohibition targets incentives directly linked to the prescription or acquisition of a specific medical device. The law, when properly interpreted, does not preclude standard business co-operation between healthcare professionals and companies, including with respect to clinical investigations and expert consultations. Importantly, it should not be read as precluding businesses from offering medical device samples to healthcare professionals or patients, as long as the distribution remains within reasonable bounds and aligns with promotional objectives.

Moreover, the Reimbursement Act imposes penalties for artificially inflating sales of reimbursed medical devices, with a maximum penalty of 8 years’ imprisonment. The law covers any actions aimed at “artificially” increasing sales of reimbursed medical devices, such as paying for prescriptions or incentivising patients to demand prescriptions or buy equipment by means of premiums, prizes or payments.

General Advertising Law Rules in Poland

Polish law outlines general rules (ie, not limited to medical devices) governing advertising and promotions. Key statutes include the Act on Combatting Unfair Competition and the Act on Combatting Unfair Market Practices, which transpose EU directives, notably Directive 2006/114/EC on Misleading and Comparative Advertising and Directive 2005/29/EC on Unfair Commercial Practices. In this context, Polish laws align with EU standards, banning misleading advertisements, instituting checks against unfair promotional practices(eg, baiting, baiting and switching), introducing limits on sales premiums, etc.

General Anti-bribery Laws and Trade in Medical Devices

As in most countries, Poland actively combats bribery activities directed to healthcare professionals, such as offering material compensation in exchange for prescriptions or the use of publicly financed medical devices.

MedTech Europe Code of Ethical Business Practice

The MedTech Europe Code of Ethical Business Practice was transposed into the ethical codes of practically every trade association representing the interests of the medical devices industry in Poland. Although not legally binding, the Code has a significant influence on all market activities in Poland. Although not legally binding, the Code holds considerable sway over market operations in Poland, especially since specific guidelines in this domain are not established in Polish legislation. Industry stakeholders often reference the Code for clarity on aspects like attending third-party events, liaising with healthcare professionals, and matters related to donations and gifts. Two trade associations (Polmed and Medtech Polska) have developed a complex national conference vetting system (“SOWE”), involving support from an impartial compliance officer, appeal compliance panel and IT platform. The procedure and regulations of SOWE closely align with the vetting system that was built by MedTech Europe and helps firms to make decisions with regard to participation in international conferences.

Pre-marketing and pre-sales requirements for medical devices in Poland result directly from MDR/IVDR and are essentially identical to those in other EU countries. Financial penalties for non-compliance with importer’s or distributor’s obligations relating to verification of medical devices to be supplied on the Polish market (see Articles 13 and 14 of MDR/IVDR) amount to approximately EUR60,000. There are however some differences regarding distribution obligations and accessing the publicly financed market.

Distribution Notification

As concerns distribution obligations, all distributors having a registered seat in Poland (this does not extend to distributors having a seat in other EU countries) must notify the Polish competent authority when first introducing a medical device to the Polish market. Until July 2024, this is to be executed by means of a special form. Attachment of product instructions, labels and promotional materials is required. Although meeting this obligation does not affect the legality of trade in medical devices, many recipients (in particular public hospitals) tend to attach excessive weight to the execution of the said notification. Occasionally, suppliers face challenges where they are pressured to demonstrate that they have submitted the distribution notification to the Polish competent authority. Failure to provide such evidence can result in reluctance or outright refusal by certain entities to enter into or uphold supply contracts. While this stance does not have a solid legal foundation, it can nonetheless create significant business complications.

The notification forms will become obsolete on 01 July 2024 and the notification obligation will then be executed by means of a dedicated IT platform (wykaz dystrybutorów). This platform has already been made available by the Polish Competent Authority but distributors may still opt for the conventional form until 01 July 2024.

Market Access

Public financing of medical devices in Poland is complicated from both a legal and a business perspective. The three central elements include:

• the “classic” reimbursement system;
• a generic list of medical devices financed publicly; and
• other instances where medical devices are publicly financed directly or indirectly through available healthcare procedures.

The “classic” reimbursement system was designed primarily with respect to medicinal products, however, it also covers several other categories of medical devices (wound care products, glucometer stripes, needles). New categories may be introduced if reimbursement criteria are met. These criteria involve price, efficiency, safety (a full health technology assessment analysis is expected), availability of public funds, the interest of patients etc. The reimbursement decision is made with respect to individual products (not product categories), identified by their Global Trade Item Number. Products that fit into existing reimbursement categories are easier to be placed within the system. However, the inclusion requires formal price negotiations with the Ministry for Health’s Economic Commission until an agreed price is reached.

If the product is reimbursed, it can be sold in Polish pharmacies at a decreased price (30%/50%/full) for patients; the remaining price is financed by the National Health Fund. The law requires that reimbursed devices are supplied to pharmacies by pharmaceutical wholesalers only. Sales to hospitals may be made at a price below the fixed reimbursement price (ie, the price agreed upon with the Ministry will, in this case, be treated as a “ceiling” price).

The patient reimbursement mechanism does not extend to hospitals. Reimbursed medical devices to hospitals may be delivered by any distributor (not just the holders of pharmaceutical wholesale licenses, as is the case with regard to pharmacies); however, there is an ongoing legal ambiguity stemming from the law’s unclear provisions. Consequently, some hospitals request that reimbursed medical devices are supplied by pharmaceutical wholesalers. However, such a requirement does not align with a proper interpretation of the law.

The Minister for Health crafts a generic list of medical device categories through an executive order. The list contains dozens of different medical device categories (orthopedic devices, stoma equipment, catheters, hearing aids, prostheses, orthoses, etc). The list contains price limits, eligible persons and prescribers, and public co-payment levels (ranging from 50% to 100%) for each category.

The list undergoes periodic revisions. Given the absence of a formalised procedure for adding categories, the Minister for Health retains the autonomy to adjust and refine the list. If a medical device fits into the existing category on the list, it may be sold at a reduced price (subject to co-payment by the National Health Fund) by retail firms holding a special permit (expert supply stores or pharmacies). In this arrangement, device producers and wholesale suppliers do not have any legal obligations or rights.

In other cases, medical devices are financed indirectly through the National Health Fund (NHF) as part of the remuneration for healthcare services that the NHF contracts with hospitals and healthcare facilities. In most cases, the payment is made through the diagnosis-related groups (DRG) system. However, in some cases, the NHF simply covers the costs based on the sales invoice (for example, baclofen pumps). In other cases, more sophisticated remuneration mechanisms are in place (for example, implantable lenses).

There are no specific laws relating to internationalisation of the medical devices produced in Poland. As Poland is an EU member, devices produced in accordance with EU legislation are free to circulate in EU+EEA zones.

It is worth highlighting the significant roles played by two governmental agencies in bolstering export and trade endeavours of Polish enterprises: the Polish Agency for Enterprise Development and the Polish Investment & Trade Agency.

All post-marketing obligations as well as market monitoring measures in the field of medical devices in Poland result directly from EU laws (MDR and IVDR). The Act on Medical Devices provides powers to the Polish competent authority to supervise and enforce these obligations. The practice of the Polish competent authority does not differ from the practice of its counterparts in other EU countries. All surveillance activities, such as Field Safety Corrective Action, recalls etc, are executed in a standard way and communicated publicly on the official website. In case of non-compliance with the competent authority’s decisions, a firm might face a penalty of up to approximately EUR120,000.

Under Polish law, all serious incidents involving medical devices must be reported to the producer, authorised representative (if applicable), as well as the Polish competent authority. The penalty for non-compliance amounts to approximately EUR12,000.

The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych or URPL) is designated as the competent authority under the MDR/IVDR. This agency has statutory powers and is responsible for ensuring that MDR/IVDR requirements are followed.

Some inspection powers over trade in medical devices are delegated to the Pharmaceutical Inspection (Inspekcja Farmaceutyczna), which is comprised of a national (Chief Pharmaceutical Inspector, Główny Inspektor Farmaceutyczny or GIF) and a local level (District Pharmaceutical Inspector, Wojewódzki Inspektor Farmaceutyczny or WIF). These authorities inspect trade in medicinal products and other goods, including medical devices, by pharmaceutical wholesalers and pharmacies.

The URPL has powers to inspect any firm involved in the production, clinical investigation or trade (including import and export) of medical devices. The URPL may impose penalties, implement monitoring measures (market recalls, orders to cease trading medical devices, etc), issue opinions and decisions as to the status and classification of a medical device, etc. The financial penalties that may be imposed by the URPL range from approximately EUR12,000 up to approximately EUR1.2 million.

The GIF holds powers to inspect pharmaceutical wholesalers and may impose penalties or even prohibit further activity in case of non-compliance. Conversely, the WIFs have powers to impose similar penalties or prohibitions with regard to pharmacies not complying with the law. WIF is also entitled to impose financial penalties of up to approximately EUR12,000 for the illegal advertisement of retail points of sale that refer to a medical device.

The Polish Act on Medical Devices provides the competent authority with powers to impose financial penalties of up to approximately EUR1.2 million for breach of safety requirements, including placing on the market a medical device that is not compliant with MDR or IVDR regulations. There is no criminal liability for offences of this kind, and no specific criminal law provisions with respect to medical devices, save for general criminal law provisions regarding triggering explosions (eg, gas installations), releasing radiation (eg, CT, RTG, brachytherapy equipment, etc) or spreading pathogens.

As an EU member, Poland transposed Council Directive 85/374/EEC of 25 July 1985 concerning liability for defective products. When interpreted literally, the Polish provisions suggest a very broad liability encompassing not just manufacturers, quasi-manufacturers, and importers, but distributors as well. However, in court practice the law is interpreted narrowly, in accordance with the wording of the Directive and distributors are not held liable for product defects originating from earlier stages of the marketing process.

The problem with the classification of standalone computer applications, including SaMD (Software as Medical Device), as “products” within the meaning of the Directive, has not been resolved in Polish jurisprudence. The same applies to SaMD utilising solutions based on artificial intelligence algorithms. Most lawyers are of the opinion that such goods are not “products” within the meaning of Directive 85/374, unless they form a single product with their carrier (a physical device). Currently, no decisive legal precedent has been set on this matter.

Consistent with other legal systems, distributors in Poland can face tort liability for any negligent actions or omission directly attributable to them (eg, improper product storage or handling). Typically, their liability is confined to statutory or private warranty obligations, such as reduction of price, repairs, or product replacements. This legal practice in Poland mirrors that of other EU nations.

The Polish judicial system is intricate due to its stringent formalities. Drafting legal documents, such as statements of claims, demands meticulous compliance with frequently changing statutory standards. Missteps or omissions can jeopardise the outcome of a case or prolong its duration significantly.

In business cases, there can be considerable gaps between court hearings, sometimes spanning up to a year. Typically, court cases extend over a period of three-five years, with complex matters often requiring even longer.

Polish judicial proceedings are similar to the German and French models, characterised by a dominant role played by the presiding judge.

Standard court fee amounts to 5% of the value of the dispute. In business cases, it is highly unlikely that the court would grant a fee reduction. Lawyers’ fees differ greatly across the market.

Any final decision made by a public administrative authority, such as the aforementioned URPL, GIF or WIF, may be appealed against to the administrative courts. The courts comprise two instances: district courts and the Supreme Administrative Court. The administrative courts have powers to temporarily suspend the effect of an unfavourable administrative decision. Proceedings before the courts (where both instances are involved) typically last from one to three years.

Although admissible and available under Polish law, class actions are not favoured by Polish lawyers due to the large number of formal uncertainties related to this form of proceedings. There is no history of any class actions related to medical devices.

Over the years, mediation has increasingly gained traction as a preferable alternative to lengthy and expensive court proceedings. While parties inherently have the right to opt for private mediation, the procedural law in Poland grants courts ample latitude to refer cases for mediation. Court-initiated mediation costs are capped at approximately EUR500.

Arbitration is another avenue available for dispute resolution in Poland. Several renowned arbitration courts exist, and this method of dispute resolution is also becoming more popular. For medical device companies that are members of the Polmed Trade Association, disputes related to ethical market conduct can be adjudicated by a Disciplinary Court, consisting of elected representatives from member companies.

Evidence collected by The Polish competent authority or public prosecutor in the course of their respective actions might be used in civil law case, such as a product liability case against a medical devices producer/importer. Conversely, expert opinions produced for civil courts may influence any possible administrative or criminal law decision. However, there is no direct link between the administrative, criminal and civil liability regimes.

Currently, there are no anticipated policy changes concerning the Polish market.

Post the enactment of the Polish Act on Medical Devices in 2022, there are no plans for introducing new legislation.

AI is a widely discussed topic in Poland, as many software producers using AI algorithms are based in Poland. The whole market awaits the AI Regulation, which is in the final phases of the EU legislative process and is expected to be effective from 2026. Meanwhile, market legal problems focus on clinical investigations relating to AI products, as well as certification and conformity procedures. The doubts and uncertainties in this domain are similar to those encountered in other EU nations.