A Notified Body is a government-supervised organization designated by a member state of the European Union to test the suitability of various products before they are placed on the market. The European Commission also maintains a database of Notified Bodies called Nando (New Approach Notified and Designated Organisations). In medical technology, they are also responsible […]
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 […]
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?