Art. 113

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.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

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 added to the text: 2030-12-31 · dates removed: 2028-05-26

Point (f) is reworded to tie the application of the listed provisions to when the electronic systems referred to in Article 30(2) become functional, removing the earlier wording that conditioned this on Eudamed not being fully functional by 26 May 2022 due to unforeseen circumstances, and it now also lists Article 51(5), Article 74(1) to (13) without prejudice to Article 74(14), and Article 110(3d) among the affected provisions, replacing the prior reference to Article 74(1) to (13) and the second sentence of the first subparagraph of Article 110(3).

New points (fa), (fb), (fc) and (fd) are added, setting out obligations for manufacturers and notified bodies to enter information into the electronic system referred to in Article 30(2) within specified periods after the date set out in point (f), and imposing registration duties tied to PSUR submission and vigilance reporting under Articles 81(2), 82 and 83.

Point (j) changes the date from which Article 5(5), point (d), applies from 26 May 2028 to 31 December 2030.

Cited: Art. 113, v2 · Art. 113, v1

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in force 2022-01-28 MODIFIED§

Amended by Regulation (EU) 2022/112 32022R0112

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: 2024-05-26, 2028-05-26

Point (h) now ends with a semicolon instead of a full stop, and two new points, (i) and (j), have been added after it.

Point (i) states that Article 5(5), points (b), (c) and (e) to (i), shall apply from 26 May 2024, and point (j) states that Article 5(5), point (d), shall apply from 26 May 2028, neither of which appeared in the earlier text.

Cited: Art. 113, v2 · Art. 113, v1

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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: 2029-05-26 · dates removed: 2023-11-27

Point (a) no longer sets a fixed date of 27 November 2023 for Article 27(3) (renumbered as Article 26(3)) and Article 51(5), instead tying their application to 18 months after the later of the dates referred to in point (f).

Point (g) changes the application date for the procedure set out in Article 74 from 26 May 2027 to 26 May 2029, still without prejudice to Article 74(14).

Cited: Art. 113, v1

text before / after, on the event page →