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.
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.
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.
KIELTYKA GLADKOWSKI KG LEGAL AGAIN CONFIRMS ITS LEADING POSITION IN POLAND
We are honoured and very pleased to inform that according to the new ranking of the Legal500 for 2025 KIELTYKA GLADKOWSKI KG LEGAL has been ranked as the leading law firm in Poland. We have been ranked in three major categories: Data Privacy and Data Protection; Healthcare and Life Sciences; Private Client.
Intellectual property (IP) is playing an increasingly important role as a component of business value. Modern companies base their operations on intangible assets such as patents, trademarks, copyrights or trade secrets. Proper valuation of intellectual property plays an important role both in shaping business strategy and in transaction processes – especially mergers and acquisitions, as well as in technology licensing. Proper estimation of IP value also affects tax and investment aspects. For this reason, companies must pay special attention to the analysis of their intangible assets in order to fully use their potential. This raises questions about how to effectively value IP and how EU and national regulations address this issue.
