The revolution in the medical devices market continues!

We have prepared a short guide for you on the changes brought by the new Polish act on medical devices. For better understanding, we will start with the key issues for this topic.

In 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) was adopted. The regulation was supposed to apply from 2020, but in the face of the coronavirus pandemic, its application was postponed by a year.

The main goal of the MDR is to introduce uniform Community regulatory frameworks for the medical device market in the European Union. Thanks to the new regulations, the identification of devices and the supervision of entities responsible for their manufacture and distribution will be easier. The new regulations impose a number of obligations on manufacturers and distributors of medical devices. Mandatory marking in the form of codes on labels and packaging will be required depending on the class of the medical device.

In terms of labeling, the MDR regulation introduces two important issues:

• a mandatory statement informing that a given product is a medical device or the necessity of using a harmonized symbol,
• placing the UDI code carrier on the product label.

Placing the UDI code on labels is obligatory for medical devices. All devices are subject to UDI coding, with the exception of custom-made ones and those in the clinical trial phase. However, the legislator provided for the introduction of transitional periods for the new regulations. For Class III devices until May 26, 2021, for Class IIa and IIb devices until May 26, 2023. Manufacturers of Class I devices have the obligation to place the UDI code on the product labeling from May 2025.

UDI as an important component of the MDR

UDI is an abbreviation from English, standing for Unique Device Identification. It is a system designed for the proper identification of medical devices.

As a result of implementing UDI, we will lead in the long term to increased patient safety and improved efficiency in the supply chain within the healthcare area. Thanks to the system, unambiguous identification of medical devices will be possible. The obtained data will allow for the limitation of selected medical errors, more effective monitoring of adverse events, and more efficient withdrawal of defective medical devices from the supply chain.

Regulations concerning UDI were developed by the US Food and Drug Administration, the European Commission, and other global regulatory bodies. Their goal is to increase patient safety, raise the quality of healthcare, and streamline business processes in the broadly understood healthcare sector. The UDI system is precisely intended to take care of the realization of these tasks in a global dimension. More and more medical devices will be labeled in a uniform manner.

Adapting polish legislation to the EU Regulation: what manufacturers should know to prepare for the new legal reality?

In April 2022, President Andrzej Duda signed the act on medical devices, which is to adapt Polish law to the European regulation 2017/745. The new act is to apply from May 26, 2022. It will organize the ambiguous regulations that have applied so far in the legal order in Poland. We were indeed dealing with a situation in which it was necessary to directly apply the EU regulation with the 2010 act on medical devices being unadjusted to the current situation. The act on medical devices is to ensure the proper application of the aforementioned regulation and the smooth functioning of the internal market in the area of medical devices and in vitro diagnostic medical devices. Changes concern the obligation to transmit, among others, information and declarations of conformity, instructions for use, as well as labeling and promotional materials introduced to the market within Poland. This obligation is to concern manufacturers, authorized representatives, entities assembling medical devices, or entities sterilizing systems or treatment sets.

What else will change?

To a large extent, the Polish legislator goes beyond the regulations of European ordinances. This will force international companies to adapt to Polish specifics. In the act, one should primarily pay attention to:

• New rules for conducting advertising and promotion of medical devices – a very important issue because it concerns both large international companies and small sole proprietorships. The regulations will apply from January 2023. Advertising of medical devices will be significantly more difficult. What will the changes consist of? The new act introduces a provision that advertising directed to the public will have to be formulated in a way understandable to a layperson. It will also no longer be possible to use the image of persons practicing medical professions, and persons presenting the product will not be able to suggest such a profession. Interestingly, direct calls to action (CTA) directed at children are also to disappear from advertisements. The act introduces high administrative penalties for non-compliance with the new regulations, but it also provides for transitional periods until June 2023. Pursuant to Article 55 of this act, it is prohibited to advertise devices intended for use by users other than laypersons.
• New administrative penalties for non-compliance with the act and regulations – the new regulations surprise with the amount of potential penalties (from PLN 2 million up to even PLN 5 million). The scope of these regulations is also surprising. Penalties are foreseen for introducing a non-compliant device to the market, but also for the lack of concluding an agreement regulating the principles of storing the technical documentation of the device.
• Change of regulations in the scope of tax on goods and services – provides for the possibility of applying a reduced 8% VAT rate to almost all medical devices.
• New requirements in the scope of Polish language versions – essentially boils down to having an interface in the Polish language.

Summary

In summary, the revolution in the medical device market is ongoing. The introduced changes will significantly affect the medical device market. According to experts, most Polish regulations will negatively affect the market attractiveness and the business environment in Poland. Unfortunately, it may turn out that some medical devices will disappear from the Polish market because they will not be able to meet the new requirements. Thus, the market value will fall. Good preparation for the new regulations will be of great importance. Particular attention should be paid to such aspects as: verification of previous advertising activities and proper external communication of the company. Further labeling of devices taking into account the Polish interface is necessary. It is also recommended to conduct audits in terms of legal risk related to monetary penalties and optimization of activities in terms of VAT tax rates – the possibility of using the reduced 8% tax rate.