emendrix

Art. 74

In Vitro Diagnostic Medical Devices Regulation · 32017R0746 · every event for this act · on EUR-Lex

3 changes recorded across 3 events, newest first.

in force 2025-01-10 MODIFIED±0

Amended by Regulation (EU) 2024/1860 32024R1860

applies from: unknown

Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.

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in force 2024-07-09 MODIFIED

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: 2029-05-25, 2029-05-26

Paragraph 14 no longer sets the mandatory application of the coordinated assessment procedure by reference to the fixed date of 26 May 2029, and instead ties mandatory application by all Member States to a date calculated as 5 years from the publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745 confirming that the electronic system under Article 30(2), point (e), is functional.

The earlier fixed cut-off of 25 May 2029, before which the procedure applied only to Member States that had agreed to use it, is replaced with a period defined as before that new calculated date and at the earliest six months from the publication of the same notice.

Cited: Art. 74, v2 · Art. 74, v1

text before / after, on the event page →

detected 2026-08-12 MODIFIED

no amending act named

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2029-05-25, 2029-05-26 · dates removed: 2029-05-27

Paragraph 14 changes the date marking the end of the voluntary application period for the coordinated assessment procedure from 27 May 2029 to 25 May 2029.

It also changes the date from which all Member States are required to apply the procedure from 'after 27 May 2029' to 'from 26 May 2029'.

Cited: Art. 74, v1 · Art. 74, v2

text before / after, on the event page →