POLAND Trends and Developments Contributed by: Marta Sroka-Maleta, Andrzej Siwiec, Katarzyna Kroner and Maciej Adamczyk, DBS Law Firm
on advertising that is misleading or worded in a way that may cause anxiety or pressure the patient to take advantage of the pharmacy’s offer. The draft act passed the public consultation stage but met some criticism. Certain experts pointed out that the proposed definition of pharmacy advertis- ing is overly broad as it includes “information”, which should be neutral. It contradicts existing case law, legal doctrine and the CJEU ruling. In practice, it risks maintaining or even deepening interpretative uncer- tainty. Criticism also concerns the criteria for prohib- ited advertising, including advertising that is contrary to good morals, which would give authorities broad discretion in assessing such advertising. The Legislative Council operating under the Prime Minister gave a positive opinion on the draft, although it also noted its shortcomings. The Council agreed with many of the experts’ comments and indicated they will be taken into account when preparing the final draft, so it does not contain provisions allowing for authorities’ discretion, while ensuring the justified need to protect patients. Trends in the Medical Device Sector in Poland 2026 will bring further harmonisation of the medical device market. The direction of change is primarily determined by actions at the EU level, in particular the planned amendment of Regulations 2017/745 (MDR) and 2017/746 (IVDR) and the announcement of the full functionality of the four modules of the EUDAMED system (the EU database for medical devices). The planned amendment to EU regulations will con- sequently require adjustments to the provisions of the Polish Medical Devices Act of 7 April 2022. In turn, the full implementation of EUDAMED will mean, in practice, the phasing out of national notification and reporting procedures for medical devices placed on the domestic market. For manufacturers, importers and other entities operating in Poland, this means not only a technical change (registration in the EU sys- tem instead of the national system), but also a simpler registration process, easier traceability of entities and devices in the supply chain, and better availability of information.
A clear trend is the intensification of supervisory activi- ties carried out by the President of the Office for Reg- istration of Medicinal Products, Medical Devices and Biocidal Products, which means that the number of administrative proceedings concerning violations of regulations relating to medical devices is growing. The authorities are increasingly analysing not only the formal aspects of operations, such as the cor- rectness of documentation or database entries, but also the content of market communications, including messages that may be misleading, materials aimed at laypersons or suggestions of therapeutic properties that go beyond the declared purpose of the device. The decisions issued reflect the growing importance of supervision and the consistent enforcement by the authority of its obligations under the Medical Devices Act. Case law concerning product classification is also of great importance in ensuring regulatory compliance, as it shows how crucial it is to correctly determine the regulatory status of a device and to ensure that the documentation complies with its actual intended use. Disputes between authorities and businesses over the boundary between a medical device and personal protective equipment or a general-purpose product remain one of the practical challenges of the market. An example is the case heard by the Provin- cial Administrative Court in Gdańsk, concluded with a judgment of 28 August 2025, concerning medical clothing registered for marketing as a Class I medi- cal device. The customs and tax inspection authority (due to the preferential VAT rate) questioned this clas- sification, considering that the product did not meet the definition of a medical device under the MDR. However, the court did not share this assessment and pointed out that the key factor in classifying a product is its intended use as specified by the manufacturer, which is a fundamental element of the definition of a medical device. Therefore, these products are medi- cal devices, not hygiene products. This judgment is not yet final. From the perspective of the medical device market, adapting to changing legal realities is becoming a key element of business. It is becoming increasingly clear that the sector is moving from a stage of adapt- ing to new regulations to a stage of enforcing them.
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