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Consolidated 10.01.2025

The full consolidated text of Regulation (EU) 2017/746, article by article — searchable, cross-referenced and citable.

Article 30
Article 30

European database on medical devices

1.
The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745.
2.

Eudamed shall include the following electronic systems:

(a)

the electronic system for registration of devices referred to in Article 26;

(b)

the UDI database referred to in Article 25;

(c)

the electronic system on registration of economic operators referred to in Article 27;

(d)

the electronic system on notified bodies and on certificates referred to in Article 52;

(e)

the electronic system on performance studies referred to in Article 69,

(f)

the electronic system on vigilance and post-market surveillance referred to in Article 87;

(g)

the electronic system on market surveillance referred to in Article 95.

This tool is provided for convenience only and has no legal effect. Only the texts published in the Official Journal of the European Union are authentic. Source: EUR-Lex, CELEX 02017R0746-20250110, © European Union. Reuse is authorised provided the source is acknowledged.