in force 2024-07-09 MODIFIED+138 −410§
Amended by Regulation (EU) 2024/1860 32024R1860
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates removed: 2021-03-25
The first paragraph no longer contains the sentence about the implementation plan seeking to ensure Eudamed is fully functional in time for the Commission to publish the paragraph 3 notice by 25 March 2021 and for other deadlines under Article 123 of this Regulation and Article 113 of Regulation (EU) 2017/746 to be met.
The second paragraph changed from referring to the Commission verifying, based on an independent audit report, that Eudamed as a whole has achieved full functionality and meets the specifications, to referring to the Commission verifying, based on independent audit reports, that one or more of the electronic systems referred to in Article 33(2) are functional and meet those specifications.
Cited: Art. 34, v1 · Art. 34, v2
text before / after
02017R0745-20230320 → 02017R0745-20240709
Article 34
Functionality of Eudamed
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 25 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 when reports, it has verified that Eudamed has achieved full functionality one or more of the electronic systems referred to in Article 33(2) are functional and Eudamed meets meet 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 the Official Journal of the European Union.