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 person who is probably already working at maximum capacity. Companies may have to have their products recertifiedas previously “normal” products will be classified as medical, and all of this will also have to be entered into EUDAMED.

Particularly the MDR database will lead to a lot of extra work for manufacturers. An extensive familiarization with it is necessary to comply with the regulations. Do I register as a Local Actor Administrator (LAA) or a Local User Administrator (LUA)? Which obligations do I have with which role? Who else in my company has the capacity to deal with EUDAMED? The simplest solution is the outsourcing of EUDAMED user roles.

Local Actor Administrator (LAA) & Local User Administrator (LUA)

There are five different user profiles for manufacturers in EUDAMED: LAA, LUA, proposer, confirmer, and lastly, viewer. The first person to register for a company automatically becomes the LAA. In addition, this role also has all the rights of the LUA. As an LAA, you have the right to manage the actor data, that is, name, contact data as well as address of the company, and the role of the individual users. Furthermore, the LAA is responsible for user requests. That means they determine which user has which rights in EUDAMED for their company. A person with good MDR knowledge should hold this role. The European Commission also recommends having at least two Local Actor Administrators. In case of the absence of one LAA can thus be compensated. The LUA is very similar to the LAA. They also manage user profiles, but not the actor data.

Proposer, Confirmer & Viewer

All users of EUDAMED are already viewers when they register. As the name suggests, they have read-only rights for all modules of EUDAMED. To register a new device in EUDAMED, a proposer and a confirmer are required. Proposers can create, edit or delete drafts for new entries. However, they cannot submit drafts in EUDAMED. This again requires a confirmer. Confirmer can also create, edit, or delete drafts. In addition, they can also submit or reject drafts. These roles and the associated rights are assigned by the LAAs or LUAs. Their roles are in the UDI and the Vigilance Module.

How does tracekey help?

Questions about external delegation also arise in the European Commission’s Actor Module FAQ. By the outsourcing of EUDAMED-specific tasks, tracekey can support companies selling medical devices. This support can take different forms. Depending on your needs, it makes sense to outsource the Local User Administrator, the proposer, or even both roles. In the case of the LUA, the user management is passed on to tracekey. In the case of the proposer, it is the work steps from the UDI Module, i.e., the product data management. However, the confirmation of the product data, namely the role of the confirmer, remains with the company itself. This service is also independent of the company’s own product management solution provider. With our years of experience in the RegTech industry, this part of your EUDAMED compliance would thus be in safe hands.

If you have any questions or are interested, please do not hesitate to contact us.