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 […]
With the Medical Device Regulation (MDR) coming into force, manufacturers are faced with several new obligations. This usually means more work for the same number of employees. In addition, EUDAMED does not stand out for its user-friendliness and straightforwardness. Companies have to register in EUDAMED, then the users have to be assigned their respective roles […]
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 […]
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 Identifier (UDI) and is intended to simplify the tracking of medical devices sold in the […]
Read More… from UDI Differences – Comparison between US and EU
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?
Are there SaaS solutions for EUDAMED? Of course, there are. For example, they can provide a convenient way to load larger amounts of data into the EUDAMED UDI module via direct interfaces to the database (M2M), keep it up-to-date, and cover topics such as versioning, audit trail, or validation. There are various ways of exchanging […]
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 […]