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 Workshop 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 workshop, 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?
With an M2M interface to EUDAMED, manufacturers save time, reduce errors, and easily meet regulatory requirements. In this article, we highlight the key benefits and business case for M2M. Are there SaaS solutions for EUDAMED that offer integrated M2M? Of course, there are. They can provide a convenient way to load large amounts of data […]
The European Commission regularly publishes documents to assist in the use of EUDAMED. Due to the complexity of EUDAMED as well as the multitude of instructional documents, it is nevertheless important to get an overview yourself. This way you will learn which aspects apply to your own company and your products. It is the only […]
The requirements of the EUDAMED and its six modules can quickly become confusing for its users, as can the maintenance of data. However, with the implementation date approaching, it is important to know how they will be implemented and which tools will help. Our Excel template for EUDAMED will help to simplify your work and […]