Outsourcing of EUDAMED User Roles

Outsourcing EUDAMED

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 […]

Read More… from Outsourcing of EUDAMED User Roles

EUDAMED Actor Roles

EUDAMED Actor Roles

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 […]

Read More… from EUDAMED Actor Roles

Our EUDAMED Workshop

EUDAMED Workshop

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 […]

Read More… from Our EUDAMED Workshop

Legacy Devices in the MDR

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 […]

Read More… from Legacy Devices in the MDR

EUDAMED’s Post-Market Surveillance

EUDAMED Post-Market Surveillance

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 […]

Read More… from EUDAMED’s Post-Market Surveillance