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. This database, known as Swissdamed, is being introduced in stages and consists of two main modules: the Actor and Device modules. The platform […]
The direct connection to EUDAMED, M2M, has numerous advantages. While the initial setup may be somewhat complex, it becomes manageable with a competent and experienced software partner like tracekey. The M2M interface to EUDAMED (Machine-to-Machine) enables the direct and automated exchange of information between internal systems, such as the mytracekey UDI Manager software and the […]
Read More… from The M2M Interface to EUDAMED: A Technical Advantage
During the development of our mytracekey UDI Manager, we had to answer a few questions. Which functions must be included? When will the public release take place? What should the pricing look like? Various options were considered for the last question. A license model with a one-off payment, a subscription model with monthly payments or […]
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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 […]
Read More… from UDI Software as a Cloud Solution for EUDAMED
At the end of 2024, the European Commission (EC) published guidelines on data exchange with EUDAMED. They describe the three upload variants: Manual upload, bulk upload and a machine-to-machine (M2M) connection. For this purpose, their advantages and disadvantages are presented. The commission also provides an overview of the conditions under which each upload variant is […]
Read More… from EUDAMED and the M2M connection – when does it make sense?
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
EUDAMED stands for European Database on Medical Devices. It was introduced as part of the Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR). Manufacturers register their products here and store all relevant data such as certificates and studies. Thanks to this database, patients can easily access information about the medical […]