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Article 34 - Functionality of Eudamed

Comparing 20/03/2023 → 09/07/2024: 0 added, 0 removed, 2 changed Close comparison

1.The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by►M125 March 2021◄and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met.

2.The Commission shall,shall inform the MDCG when, on the basis of an independent audit report, inform the MDCG whenreports, it has verified that Eudamedone hasor achievedmore fullof functionalitythe electronic systems referred to in Article 33(2) are functional and Eudamed meetsmeet the functional specifications drawn up pursuant to paragraph 1.1 of this Article.

3.The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in theOfficial Journal of the European Union.

Official text · consolidated version 09/07/2024 (no longer in force) Open full page ↗
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