The revolution on the medical devices market continues!

The revolution on the medical devices market continues!
What will the new Polish act on medical devices change?  

We have prepared for you a short guide on the changes following the new Polish act on medical devices. For a better understanding, let us start with the key issues related to that topic.  

In 2017, Regulation 2017/745 of the European Parliament and of the Council on medical devices (MDR-Medical Device Regulation) was adopted. The Regulation was supposed to come into force in 2020, however, due to the coronavirus pandemic, its application was postponed to the following year.  

The main objective of the MDR is to introduce a single community regulatory framework for the medical device market in the European Union. The new regulations will make it easier to identify products and supervise the entities responsible for their manufacture and distribution. The new regulations impose a number of obligations on manufacturers and distributors of medical devices. Marking in the form of codes on labels and packaging, according to the class of medical devices, will be obligatory.  

The MDR regulation on labelling introduces two important points: 

• a mandatory statement that the product is a medical device or the need to use the harmonised symbol, 
• placing the UDI-code carrier on the label of the device. 

Placing the UDI code on labels is mandatory for medical devices. All products, with the exception of custom-made products and products undergoing clinical trials, are subject to marking with the UDI code. However, the legislator has ensured the possibility of introducing transitional periods for the new regulations. For Class III products - 26 May 2021, for Class II a and II b products - 26 May 2023. Manufacturers of Class I products are required to include the UDI code on the labels from May 2025.  

UDI an important element of the MDR  

UDI stands for Unique Device Identification. It is a system designed for the proper identification of medical devices. 

As a result of the implementation of the UDI, in the long run, patient safety will be increased and the efficiency in the healthcare supply chain will be improved. The system will enable the unambiguous identification of medical devices. The obtained data will allow reducing the number of certain medical errors, more effective monitoring of adverse events and more efficient withdrawal of defective medical devices from the supply chain. 

UDI regulations have been developed by the U.S. Food and Drug Administration, the European Commission and other global regulatory authorities. The goal is to increase patient safety, improve the quality of healthcare and streamline business processes in the field of broadly understood health protection. The UDI system is to ensure the implementation of the above-mentioned tasks on a global scale. More and more medical devices will be labelled in a uniform way. In this way, business processes in the area of ​​healthcare and patient safety are to be significantly improved. 

Adaptation of Polish legislation to the EU regulations What should the manufacturers be aware of 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 come into force on 26 May 2022. It will put in order the ambiguous provisions that have existed in the legal sphere in Poland so far. We had to deal with cases that required the implementation of the EU regulations directly, and the Act on Medical Devices of 2010 was not adapted 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. The changes relate to the obligation to provide, among other things, information and declarations of conformity, instructions for use, labelling and promotional materials placed on the market in Poland. That obligation will apply to manufacturers, authorised representatives, entities that assemble medical devices or entities that sterilise systems or treatment sets.  

What else is going to change? To a large extent, the Polish legislator goes beyond the provisions of European regulations. This will force international companies to adapt to the Polish specific reality. With regard to the act, attention should be paid to, first of all:  

• New rules on advertising and promotion of medical devices - it's a very important issue as it applies to large international companies and to small one-person businesses. The regulations will be in force from January 2023. Advertising medical devices will definitely be more demanding. What will the changes involve? The new act introduces a provision that an ad addressed to the public will have to be formulated in a way that is understandable by a layman. Also, it will no longer be possible to use the image of healthcare professionals, and persons who will present the product will not be able to suggest such a profession. Interestingly, direct CTAs (call to action) addressed to children are also to disappear from advertising. The act introduces heavy administrative penalties for non-compliance with the new regulations but also ensured the possibility of introducing transitional periods - until June 2023. Pursuant to Art. 55 of the Act, it is prohibited to advertise products intended for use by users other than laymen. 
• New administrative penalties for non-compliance with the Act and the regulations - the potential penalties for non-compliance with the new regulations are surprisingly high (from PLN 2 million to even PLN 5 million). The scope of the regulations is also surprising. The Act provides for penalties for placing a non-compliant product on the market but also for failing to conclude an agreement regulating the rules for storing the technical documentation of the product.  
• Amendment to the VAT legislation - the possibility to apply a reduced 8% VAT rate to almost all medical devices.  
• New requirements for Polish language versions - it basically means the necessity to have the interface in Polish.  

To sum up, the revolution on the medical devices market continues. The introduced changes will significantly affect the market of medical devices. According to experts, most of the Polish regulations will have a negative impact on the attractiveness of the market and the business environment in Poland. Sadly, it may turn out that some medical devices will disappear from the Polish market because it will be difficult to meet the new requirements.Thus, the value of the market will fall.  It will be important to be well prepared for the new regulations. Particular attention should be paid to such aspects as: verification of advertising activities to date and proper external communication of the company. It is necessary to continue to label products taking into account Polish interface. It is also recommended to perform audits in terms of the legal risk related to fines and to optimise the activity in terms of VAT rates - the possibility to benefit from the reduced 8% VAT rate. Prespack constantly monitors changes in legal regulations. We will do our best to help our present and future customers implement them properly.