Publication date: March 31, 2025
The meeting was devoted to the classification of medical devices. The main topic was the technical and legal classification and certification of medical products and diagnostic devices before they are introduced to the market. This process is very time-consuming and even very expensive.
It is worth using the help of a company that provides assistance in this procedure during this process. It is important that this company is a notified body, a conformity assessment body designated in accordance with Regulation 2017/745. Then you can be sure that a given product intended to take care of human health will be properly put into clinical trials and will be safe for people.
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Publication date: March 31, 2025
The healthcare sector is one of the most challenging areas of innovation, characterized by high complexity, strict regulations, high development costs and cultural diversity in different countries. Despite technological progress, fragmentation of innovation ecosystems in digital health is a significant barrier to effective cooperation and implementation of new solutions. The COHES.io project (Connected Health Ecosystems via Open Innovation), which aims to create an interregional space for open innovation in digital health, is the response to these challenges.
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Publication date: March 31, 2025
In recent years, there has probably been no more dynamically developing market sector than that closely related to the production of drugs, their testing and introduction to consumer circulation. Especially during the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus, all the efforts of pharmacists around the world have been focused on developing an effective formula for a vaccine protecting against infection with this disease, producing it, testing it and making it available to people, and in the longer term on developing a formula for a drug that could be widely used, e.g. in hospitals. No less important at that time were the problems and legal issues related to obtaining permission to produce drugs. In this article, there will be discussed detailed regulations related to the procedure for obtaining consent to manufacture drugs, which is regulated in the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), as well as to present the requirements imposed on drug factories in terms of building equipment and production principles, which are regulated in other sub-statutory legal acts.
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The limits of trade in medicinal products in Poland are strictly defined by legal regulations. The main source regulating the sale of medicines is the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686, as amended) (hereinafter referred to as “Pharmaceutical Law”). Art. 2, point 32 of the aforementioned Act states that a medicinal product is a substance or mixture of substances presented as having properties for the prevention or treatment of diseases occurring in humans or animals or administered for the purpose of making a diagnosis or for the purpose of restoring, improving or modifying the physiological functions of the body through pharmacological, immunological or metabolic action. Pharmaceutical Law presents principles that define the rules of trade in such products.
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Publication date: March 05, 2025
Methods of transporting medical samples
Transport of medical samples is an essential element of the laboratory diagnostics process, the primary goal of which is to ensure the integrity, stability and quality of biological material at every stage of its movement – from the moment of collection to analysis in the laboratory. Properly organized transport minimizes the risk of sample degradation, contamination, loss of their diagnostic value and potential biological threats to medical personnel and the environment. In addition, precise adherence to transport standards, including appropriate temperature conditions, delivery time and compliance with applicable regulations and procedures, is crucial for obtaining reliable laboratory test results. Below are the main methods of securing medical samples by suppliers during transport.
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