Article 2 · Eudamed · GlobalLawDB

Contents

Article 2Modes of access#

1.Eudamed shall be accessible for authorised users via a restricted website (‘the restricted website’) and for non-identified users via a public website (‘the public website’).

2.Eudamed shall be accessible through machine-to-machine data exchange services to competent authorities as referred to in Article 101 of Regulation (EU) 2017/745 and Article 96 of Regulation EU 2017/746 (‘competent authorities’) and notified bodies registered in Eudamed in accordance with Article 3 of this Regulation. The Commission shall provide each Member State and notified body with data exchange access points enabling them to use such data exchange services upon their request.Eudamed shall be accessible through machine-to-machine data exchange services to actors other than the competent authorities and notified bodies, provided that the LAA of the actor concerned submits a request for such access as referred to in Article 3(8), first subparagraph. The Commission shall approve that request under the condition set out in Article 3(8), second subparagraph.

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Defined terms · 5

Show every defined term

actor
means 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 user
means 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;
malfunction
means 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.