actormeans the Commission, a competent authority, an authority responsible for notified bodies, a notified body, a manufacturer, an authorised representative, an importer, a system or procedure pack producer or a sponsor, who has been registered in Eudamed in accordance with Article 3 of this Regulation in order to fulfil its obligations set out in Regulations (EU) 2017/745 and (EU) No 2017/746;
authorised usermeans a natural person who has been granted access to Eudamed via the restricted website to act on behalf of an actor;
local actor administrator(LAA) means an authorised user who has the right to manage certain information regarding the details of the actor and to grant access to Eudamed via the restricted website to other natural persons to act on behalf of that actor;
local user administrator(LUA) means an authorised user who has the right to grant access to Eudamed via the restricted website to other natural persons to act on behalf of an actor;
malfunctionmeans a significant failure of the functioning of Eudamed, including any failure caused by unforeseeable circumstances or by force majeure, that could adversely affect the IT security or hinder the availability of any of the functionalities of Eudamed’s electronic systems referred to in Article 33(2) of Regulation (EU) 2017/745.