MedTech News Archive - Page 2 of 7 - tracekey solutions GmbH

Vigilance in the MDR

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 […] […]

How to Develop an International UDI Strategy Based on EUDAMED-UDI

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. […] […]

The EUDAMED SRN Number (SRN) – FAQ answered

Single Registration Number (SRN) for EUDAMED

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) for Medical Devices

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 […]

swissdamed: Swissmedic’s Database

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 M2M Interface to EUDAMED: How integration works

M2M-Schnittstelle zur EUDAMED; M2M Connection to EUDAMED

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 […]

Pay-As-You-Use | How our pricing model 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 […]

Challenges of the MDR – Our EUDAMED Solution

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. […]

UDI Software as a Cloud Solution | Secure UDI Data Management for EUDAMED

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 […]

EUDAMED and the M2M connection – When is the interface worthwhile?

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 […]