Source

Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council

Decision (EU) 2025/2371 · Decision · 2 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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It is hereby confirmed that the following electronic systems included in the European Database on Medical Devices (Eudamed) have achieved functionality and meet the functional specifications, as referred to in Article 34(2) of Regulation (EU) 2017/745: (a) the electronic system on registration of economic operators referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746; (b) the UDI database and the electronic system for registration of devices referred to in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746; (c) the electronic system on notified bodies and certificates referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746; (d) the electronic system on market surveillance referred to in Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.

Article 2

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This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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