Actor roles in the EUDAMED system.

Hi Folks,

This is an excerpt from a useful document created by the European Commission to give guidance on the Actor roles in the EUDAMED system. If you are an economic operator you are most likely an actor and therefore have to register to be compliant with the MDR 2017/745. This module went live at the beginning of Dec 2020.

The document explains who needs to register as an actor in EUDAMED regarding monitoring the regulation system. You have the European Commission, the competent authority the body who designates the notify body who is usually the competent authority and the notified body.

Notice that Nando is mentioned here as well. The acronym stands for (New Approach Notified and Designated Organisations) Information System. It is a list of NBs that are compliant to perform MDR conformity assessments.

Now let me draw your attention to the right-hand side. Who from the economic operators needs to register as an actor in the EUDAMED system? The manufacturer, the authorised representative, the system & procedure pack producer and the importer. It is interesting to note that the distributor does not need to register.