Launching Class I medical devices on the Polish market requires precise planning and knowledge of the regulations. This guide will help you safely navigate the start-up process and meet all legal requirements, especially in the context of products such as nasenstrips and mouthtaps.
Choice of legal form for the medical sector
The limited liability company (Ltd.) is the most recommended legal form for business in the medical sector, especially when conducting online sales. Here are the most important reasons:
- Financial security: Your personal assets remain separate from your company assets and your liability is limited to the amount of the contributions made only.
- Tax benefits: Access to a wide range of tax reliefs and preferences allows business costs to be optimised.
- Business credibility: Contractors and financial institutions perceive the limited liability company as a reliable business partner, which is particularly important in the medical sector.
Business development strategy
When importing and distributing medical devices, there are several key aspects to consider:
- Regulatory analysis: Each market has its own regulations for medical devices - knowing them thoroughly will help avoid legal sanctions.
- Separation of activities: Separating the online shop into a separate company can significantly minimise business risk.
- Accountability management: A proper organisational structure protects against the accumulation of liabilities in a single entity.
Find out more about the sale of medical devices here: https://bktkancelaria.pl/wprowadzenie-wyrobow-medycznych-na-rynek-niemiecki-najwazniejsze-wymogi-prawne/.
Registration of a limited liability company. - choosing the optimal path
An entrepreneur planning to establish a limited liability company has two main registration paths to choose from. The first is registration through S24 portalwhich allows you to quickly set up a business online. The second is traditional path, requiring a visit to a notary and registration through the PRS portal.
The process of registering a company via S24 appears at first glance to be an attractive solution - it is quick and does not require in-depth knowledge of the law. However, this apparent simplicity comes at a price. Articles of association in S24 is based on a basic formula that omits many important aspects of doing business. For example, you will not find detailed regulations on increasing share capital or additional obligations of shareholders.
For entrepreneurs planning the long-term development of their company, especially in the demanding medical sector, we recommend the traditional route. Why? Contract prepared by a specialist and concluded in the form of a notarial deed provides the opportunity to regulate in detail all key aspects of the company's operation. It is like building a house on a solid foundation - it requires more effort initially, but provides stability for years to come.
The registration process through the PRS, although requiring more time and paperwork, allows you to create a legal structure that is ideally suited to the specifics of your business. A professional will help anticipate potential scenarios for the company's development and adequately safeguard the interests of all shareholders.
You can read more about the limited liability company agreement here: https://bktkancelaria.pl/umowa-sp-z-o-o/.
Introduction of Class I medical products on the Polish market
The market for medical devices, particularly products such as nasenstrips and mouthtapes, is currently experiencing significant growth in popularity across Europe. When introducing these products into the Polish market, a number of precisely defined legal requirements must be met.
Legal basis - MDR Regulation
EU Regulation 2017/745 (MDR), which came into force on 26 May 2021, is the fundamental piece of legislation regulating the medical device market in the European Union. The regulation, also known as the Medical Device Regulation, introduces comprehensive requirements for the entire life cycle of a product - from design to manufacture to marketing and supervision of medical devices.
Key aspects of MDR
The MDR regulation introduces significant changes that significantly affect the way companies operate in the medical sector. The fundamental aim of these regulations is to ensure the highest level of safety for patients and users. This is achieved by tightening the requirements for conformity assessment of medical devices and introducing more stringent inspection procedures.
Particular emphasis has been placed on transparency and traceability in the supply chain. The identification system for medical devices now has to meet much stricter requirements, which translates into safety for end users.
The regulations also introduced the EUDAMED central database, which provides a comprehensive source of information on medical devices available on the EU market. This tool significantly facilitates market surveillance and provides rapid access to key product information.
Detailed information on the requirements for packaging and labelling in the German market can be found in our comprehensive article.
Responsibility in the medical device supply chain
The introduction of medical devices into the Polish market involves a detailed liability structure that covers all participants in the supply chain. Understanding these responsibilities is key to conducting business safely and legally.
Key responsibilities of the manufacturer
At the centre of the medical device safety system is the manufacturer. Its fundamental responsibility is to appoint a person responsible for regulatory compliance (PRRC). This role is not just a formal requirement - it is a key element in ensuring continued product compliance with regulatory requirements.
The manufacturer must also implement a post-market surveillance (PMS) system, i.e. a systematic monitoring of products after they have been placed on the market. This mechanism allows rapid detection and response to potential product safety issues.
Certification and documentation requirements
Every medical device placed on the Polish market must carry the CE mark, which confirms its compliance with the MDR regulation. This requirement is combined with a comprehensive documentation process. All technical documentation, including instructions for use and labels, must be professionally translated into Polish and comply with local legal requirements.
Obligations of the importer
For importers importing medical devices from outside the EU, the law provides for additional obligations:
- Keeping a detailed register of complaints and incidents
- Verification of compliance with the MDR
- Placing the importer's details on the packaging or documentation
Registration and monitoring
The registration process for medical devices in Poland is carried out Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). In parallel, registration in the European EUDAMED database is required. For non-EU manufacturers, it is also necessary to establish an official representative within the Union.
For more information about online sales abroad, see our detailed guide.
Summary
The introduction of medical devices to the Polish market requires careful preparation and attention at every stage of the process. The key to success is understanding and fulfilling all legal, certification and documentation requirements. This complex process often requires professional support to help guide the company safely through all stages of market entry.
