emendrix

Art. 112

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

5 changes recorded across 5 events, newest first.

in force 2025-01-10 MODIFIED±0

Amended by Regulation (EU) 2024/1860 32024R1860

applies from: unknown

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in force 2024-07-09 MODIFIED

Amended by Regulation (EU) 2024/1860 32024R1860

applies from: unchanged

The cross-references to Article 110 have been changed from citing paragraphs (3) and (4) to citing paragraphs (3) to (4), and the repeal dates for the exceptions in points (a) and (b) are now tied to the date in Article 113(3)(f) alone, linked to the application of obligations and requirements relating to specific electronic systems referenced in Article 30(2), rather than to the later of the dates in Article 113(2) and 113(3)(f).

Point (a) now refers to Article 12(1), point (c) rather than point (c) of Article 12(1), and adds a reference to the corresponding Annexes to that Directive, while tying the repeal timing to the electronic systems in Article 30(2), points (e) and (f).

Point (b) similarly rephrases the reference to Article 12(1), points (a) and (b), adds the phrase concerning corresponding Annexes to that Directive, and ties its repeal timing to the electronic systems in Article 30(2), points (a) to (d), instead of the fixed 18-month period after the later of the two prior dates.

Cited: Art. 112, v2 · Art. 112, v1

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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

The clause stating that Directive 98/79/EC continues to apply to the devices referred to in Article 110(3) and (4) no longer specifies an end date of 26 May 2028, leaving the continued application unbounded by that date in the text.

Cited: Art. 112, v1 · Art. 112, 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: 2028-05-26 · dates removed: 2025-05-27

The date until which Directive 98/79/EC continues to apply for the devices referred to in Article 110(3) and (4) has been changed from 27 May 2025 to 26 May 2028.

Cited: Art. 112, v1 · Art. 112, v2

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detected 2026-08-12 MODIFIED

no amending act named

applies from: unchanged

Point (b) of Article 112 now also names Article 15(5) of Directive 98/79/EC alongside Article 10 and points (a) and (b) of Article 12(1) as a provision repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3).

In the earlier version, point (b) listed only Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC.

Cited: Art. 112, v2 · Art. 112, v1

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