Art. 110

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: 2024-07-09, 2025-09-26, 2026-09-26, 2027-09-26, 2027-12-31, 2028-12-31, 2029-12-31

Paragraph 2's second subparagraph now extends validity of certificates issued from 25 May 2017 that were still valid on 26 May 2022 and not withdrawn afterwards through 31 December 2027, and adds conditions for certificates that had already expired before 9 July 2024, requiring either a signed conformity-assessment agreement or a competent authority derogation or requirement under Articles 54(1) or 92(1), where the prior text simply set a 27 May 2025 void date.

Former paragraph 3, which allowed continued placement on the market under conditions listed directly within it and used dates in 2025-2027, has been split into new paragraphs 3, 3a, 3b, 3c, 3d and 3e, moving the device categories, the conditions, and the surveillance-responsibility text into separate numbered paragraphs and changing the applicable dates to 31 December 2027, 2028 and 2029 along with new intermediate deadlines in 2025, 2026 and 2027.

A new paragraph 11 has been added stating that Article 10a also applies to the devices referred to in paragraphs 3a and 3b.

Cited: Art. 110, v1 · Art. 110, v2

text before / after, on the event page →

in force 2023-03-20 MODIFIED§

Amended by Regulation (EU) 2023/607 32023R0607

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

dates removed: 2028-05-26

Paragraph 4 previously set separate deadlines of 26 May 2025 for devices placed on the market before 26 May 2022 and staggered deadlines of 26 May 2026, 2027 or 2028 for devices placed on the market from 26 May 2022 under paragraph 3, distinguishing among device classes referenced in paragraph 3.

In the revised text these two categories are merged into a single sentence stating that both groups of devices may continue to be made available on the market or put into service, with no end dates or class-based distinctions listed.

Cited: Art. 110, v1 · Art. 110, v2

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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: 2025-05-26, 2026-05-26, 2027-05-26, 2028-05-26 · dates removed: 2024-05-27

Paragraph 2's void-by date for certificates has moved from 27 May 2024 to 27 May 2025 in both the Annex VI exception and the from-25-May-2017 category.

Paragraph 3 now sets out separate market/put-into-service deadlines depending on device class and certification route, adding a new subparagraph listing 26 May 2025, 26 May 2026 and 26 May 2027 dates for devices whose conformity assessment previously did not involve a notified body but now does, whereas the earlier text used a single continued-compliance rule without these class-based dates.

Paragraph 4 has been split into two subparagraphs, replacing the former single 27 May 2025 continued-availability deadline with a 26 May 2025 deadline for devices placed on the market before 26 May 2022 and a new set of staggered deadlines of 26 May 2026, 26 May 2027 and 26 May 2028 for devices placed on the market from 26 May 2022 under paragraph 3.

Cited: Art. 110, v1 · Art. 110, v2

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detected 2026-08-12 MODIFIED§

no amending act named

applies from: unchanged

In paragraph 4, the phrase describing devices placed on the market on 26 May 2022 was changed to describing devices placed on the market from that date.

In paragraph 8, the derogation reference was expanded to add Article 15(5) of Directive 98/79/EC alongside Article 10 and points (a) and (b) of Article 12(1), and the corresponding compliance reference was changed from Article 27(3) and Article 28(1) to Articles 26(3) and 28(1) of this Regulation.

Cited: Art. 110, v2

text before / after, on the event page →