Medical products

Medical devices play a very important role in the daily functioning of healthcare systems. From bandages to advanced medical technologies such as prostheses or monitoring devices, these products support doctors, nurses and patients in diagnosis, treatment and rehabilitation.
Their task is not only to improve the quality of life of patients, but also to ensure the safety and effectiveness of therapy. In an era of rapid development of medicine, medical devices must meet strict quality standards, especially those set by European Union regulations.

What are medical devices?

Medical devices include a wide range of tools, devices, implants, reagents, materials, software or other items intended by the manufacturer to be used individually or in combination for the applications presented below.
Medical devices are used in humans for purposes such as:

• diagnosing, preventing, monitoring, predicting, prognosing, treating or alleviating the course of diseases;
• diagnosing, monitoring, treating, alleviating or compensating for injuries and disabilities;
• testing, replacing or modifying the anatomical structure or physiological or disease processes;
• providing information through in vitro testing of samples taken from the human body, including those taken from donors of organs, blood and tissues
• regulation of conception or assisted conception products specifically intended for cleaning, disinfecting or sterilising products.

It should be noted that medical devices do not achieve pharmacological, immunological or metabolic effects in or on the human body, although their effect may be supported by such effects. Regulation 2017/745 of 5 April 2017 on medical devices contains 71 definitions of a medical device.

Are medical devices reimbursed?

Under health insurance, patients are entitled to reimbursement for selected medical devices. This includes, among others:

• wheelchairs;
• prostheses;
• orthoses;
• hearing aids;
• spectacle lenses;
• orthopedic footwear;
• anti-decubitus mattresses;
• walking sticks;
• crutches;
• diaper pants;
• catheters;
• ostomy equipment.

The amount of reimbursement and the frequency of product replacement are determined on the basis of the provisions contained in the Regulation of the Minister of Health of 29 May 2017 regarding the list of medical devices issued on request (Journal of Laws of 2024, item 500, as amended). The full list of products covered by reimbursement, as well as the amounts and periods of use, can be found in the annex to the aforementioned regulation.

Since 1 January 2020, changes have been introduced that have simplified the process of issuing and implementing orders for medical devices, which has significantly facilitated access to the necessary products, especially for the elderly and disabled and their caregivers.

Do medical devices meet EU requirements?

In Poland, medical devices are supervised by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, who is responsible for controlling their safety and compliance with the regulations. We distinguish medical devices of class I, IIa, class IIb, class III, the criteria for the class of the device are included in Annex VII of Regulation 745. In order for a given medical device to be introduced to the market, the manufacturer or its authorized representative must issue a declaration of conformity. This document confirms that the product meets the requirements specified by European Union law. Only after obtaining such a declaration can the medical device be marked with the CE symbol (Conformité Européenne), which proves its compliance with EU standards and its admission to trade in the Member States.

Products must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR), which regulates the safety, quality and effectiveness of medical devices on the European market. They undergo rigorous testing and certification procedures, which is confirmed by the CE mark, guaranteeing that they meet the highest standards of safety and effectiveness required by EU law.