The Single Registration Number (SRN) is the most important identifier for all economic operators working in EUDAMED. It serves for unique identification across Europe in the European Database on Medical Devices (EUDAMED) […] […]
Electronic Instructions for Use (eIFU) are digital versions of traditional printed instructions for medical devices. They offer numerous advantages, including improved accessibility and reduced paper consumption. The current situation in the EU, global regulations, and future requirements for medical device manufacturers are discussed in the following article. In Europe, eIFUs have been a topic since […]
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On August 6, 2024, the first module of the new Swissmedic database was released. It serves to register economic operators and medical devices, including in vitro diagnostics, which are marketed in Switzerland and Liechtenstein. This database, known as swissdamed, is being introduced in stages and consists of two main modules: the Actor and Device modules. […]
The direct connection to EUDAMED, M2M, offers many advantages. Even if the setup is a little more complex at first, this is no problem with a competent and experienced software partner such as tracekey solutions. In this article, we explain the technical implementation and the basics of machine-to-machine (M2M) communication with EUDAMED. M2M is an […]
Read More… from The M2M Interface to EUDAMED: How integration works
During the development of the UDI Manager packages, we focused intensively on how to best meet the diverse requirements of medical device manufacturers. The result: four tailor-made packages plus a customizable ENTERPRISE version, which are based on a monthly or annual base fee and supplemented by a pay-as-you-use model for additional UDIs. We explain exactly […]
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Despite some delays, the final EUDAMED deadline is not far off. Its scope remains challenging for manufacturers. The requirements of the Medical Device Regulation (MDR) are overwhelming, there are not enough capacities in the company, and the budget is also tight. At the same time, there is uncertainty about further potential changes to the MDR. […]
Read More… from Challenges of the MDR – Our EUDAMED Solution
EUDAMED is a central database and an important component of the MDR and IVDR. It is used to collect and manage information about medical devices, thereby contributing to their safety and traceability. Its goal is to create transparency for patients. They can obtain information about relevant products using the Unique Device Identifiers (UDIs). Whether it’s […]
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The M2M connection to EUDAMED enables automated data transfer for UDI information. But when is implementation worthwhile? In this article, you will learn about the advantages of M2M and for which manufacturers it is particularly useful. While the guidelines can provide a good overview, we at tracekey do not agree with every point. Therefore, in […]
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The European Union’s AI Act is a comprehensive regulation establishing a legal framework for artificial intelligence (AI) for the first time. The law was passed on May 21, 2024, and came into force on August 1 of the same year. It regulates the development, deployment, and use of AIs. The aim is to improve the […]
Counterfeit medical devices are a problem worldwide, as inferior counterfeits endanger patients’ lives. Unlike counterfeit medicines, however, there is hardly any data or established processes and regulations to help solve the problem. Medical devices form a diverse and large group with over 500,000 products. Subsequently, they are often affected by counterfeiting or irregularly removed from […]
Read More… from Counterfeit medical devices in Europe: a problem with too little data