Under the EU Medical Device Regulation (MDR), vigilance plays a key role in patient safety and transparency in the MedTech industry. EUDAMED serves as the central platform for submitting these reports. […] […]
Read More… from Vigilance Reporting in EUDAMED: An Overview for Medical Device Manufacturers
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 […]
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 […]
Read More… from Pay-As-You-Use | How our pricing model works
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