At first glance, the general differences between the In Vitro Diagnostic Directive (IVDD) and the In Vitro Diagnostic Regulation (IVDR) are not particularly significant. Regulations of the IVDD continue to exist, so to speak, but they are supplemented by additional regulations, resulting in the IVDR. For example, the obligations of economic operators, i.e., manufacturers, authorized […]
Although it still seems far away, the date of the EUDAMED deadline is getting closer and closer. However, like on Christmas, you are caught off guard by how sudden the deadline comes around the corner. Good preparation is essential to face the deadline calmly. After all, the Medical Device Regulation (MDR) and especially the new […]
Due to the Medical Device Regulation (MDR), digitalization of the medical technology industry is taking place. EUDAMED plays a instrumental role in this. Among other things, it intends to ensure the tracking of medical devices. However, it also entails a host of new tasks and obligations. Obligations will have to be taken on by a […]
The EUDAMED Actor Roles are part of the Actor Registration Module. It is the first of the six modules to be made available to the public. Each person or actor must register here before using EUDAMED. The European Union defines an actor as: A natural or legal person (organization) with a specific role that must […]
Our EUDAMED Webinar How to manage your UDI data Are you prepared for the upcoming deadline on the 28th of May 2026? The EUDAMED-UDI registration obligation is approaching. For many manufacturers, this means: act now to avoid unpleasant surprises later. In our compact EUDAMED webinar, we will show you how to upload your UDI data […]
Legacy devices are not directly mentioned in the MDR but are defined in the Medical Device Coordination Group document MDCG 2021-25. Accordingly, these are medical devices that were placed on the market after the application date of the MDR in 2021 until May 26, 2024, if certain conditions are met. Thus, circa 80% of the […]
According to the Medical Device Regulation (MDR) and the In-vitro-Diagnostic Device Regulation (IVDR), EUDAMED’s Post-Market Surveillance refers to all activities in which data is proactively collected and information is gathered about products that are already on the market. The resulting information should be available in such a way that necessary corrective or preventive measurements can […]
The Unique Device Identifier (UDI) in the EU and the US differs in some points. On September 24, 2013, a directive was passed in the United States to introduce an identification system for MedTech products, which came into force on December 23 of the same year. It comes in the form of the Unique Device […]
EUDAMED improves transparency and coordination of information on medical devices. However, it often excels in its complexity. The main component of this complexity is its six modules, of which only three are released as of today. There is no release date scheduled for the remaining three modules yet. However, EU information materials are often difficult […]
Read More… from Basics of the EUDAMED modules – What do I need to know?
The In Vitro Diagnostics Regulation (IVDR) is often mentioned in the same breath as the Medical Device Regulation (MDR). Both regulations came into force on May 25, 2017, and both replace their respective predecessors: the MDR replaces the MDD, while the IVDR replaces the IVDD. A comparison of the regulations is not far off, as […]
Read More… from IVDR Preparation – Why is it useful to start now?