Article 3 · Eudamed · GlobalLawDB

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Article 3Registration in Eudamed and access to Eudamed via the restricted website#

1.In order to be granted access to Eudamed via the restricted website, a natural person shall create an account on the Commission authentication service website.

2.The Commission shall register the competent authorities and the authorities responsible for the notified bodies and shall grant access to the restricted website to a first natural person to act on their behalf. For that purpose, the Member States shall provide to the Commission information on their competent authorities, the authorities responsible for notified bodies and the natural persons to become the first authorised users of those authorities.

3.The Commission shall register the notified bodies in Eudamed on the basis of the information in the database of notified bodies developed and managed by the Commission (NANDO).In order to be granted access to Eudamed via the restricted website, the first natural person acting on behalf of an actor that is a notified body shall submit an access request via the restricted website. The authority responsible for the notified body shall approve the request.

4.In order for other entities than the ones mentioned in paragraphs 2 and 3 to be registered in Eudamed, a natural person acting on behalf of the prospective actor shall submit an actor registration request, via the restricted website. The actor registration request shall include the signed declaration on information security responsibilities referred to in Article 10(1). A national competent authority shall approve the actor registration request, except when the request concerns a sponsor of a clinical investigation or a performance study.Upon approval of the actor registration request or, in case of a sponsor, when the actor registration request has been submitted, the natural person who submitted that request as referred to in the first subparagraph shall be automatically granted access to the restricted website and become the first authorised user, provided that the conditions in paragraph 6 are fulfilled.For the purposes of this paragraph, the national competent authority shall be the authority of the place of establishment of the prospective actor. As regards manufacturers established outside of the Union, the national competent authority shall be the authority responsible for the authorised representative mentioned in the actor registration request. As regards system or procedure pack producers established outside of the Union, the national competent authority shall be the authority of the Member State, where the first system or procedure pack of that producer is to be placed on the market.

5.In order for a natural person to be granted access to the restricted website to act on behalf of an actor, he or she shall submit an access request via the restricted website. A LAA or LUA of that actor shall approve the access request.

6.In order to become authorised users, natural persons shall accept the user rights and obligations as set out in the document referred to in Article 10(1), point (a), and consult the privacy statement referred to in point (c) of that Article.

7.The first authorised user of an actor shall automatically be the first LAA of that actor.

8.A LAA may via the restricted website make a request to the Commission for a machine-to-machine connection for performing data exchanges between the actor’s database and Eudamed.The Commission may approve the request referred to in the first subparagraph provided that the LAA has confirmed that the actor complies with the information security requirements for data exchange referred to in Article 10(1).