Authorized Representatives (ARs) carry significant responsibility toward their clients and actively contribute to traceability and product safety through collaboration with stakeholders such as importers. In this FAQ, we clarify responsibilities under MDR and […] […]
Read More… from FAQ: Authorized Representatives – Managing EUDAMED UDI Data
In the Vigilance module of EUDAMED, manufacturers, importers, and authorized representatives will be required to upload their Post-Market Surveillance (PMS) reports. For notified bodies and […] […]
Small and medium-sized enterprises (SMEs) often struggle with the complexity of the Medical Device Regulation (MDR). A clear UDI strategy can help standardize processes and ease the regulatory burden. […] […]
Read More… from How to Develop an International UDI Strategy Based on EUDAMED-UDI
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 […]
Read More… from Electronic Instructions for Use (eIFU) for Medical Devices
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 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 […]
Read More… from UDI Software as a Cloud Solution for EUDAMED