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Document 22025D2108
Decision of the EEA Joint Committee No 172/2025 of 11 July 2025 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/2108]
Decision of the EEA Joint Committee No 172/2025 of 11 July 2025 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/2108]
Decision of the EEA Joint Committee No 172/2025 of 11 July 2025 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/2108]
OJ L, 2025/2108, 6.11.2025, ELI: http://data.europa.eu/eli/dec/2025/2108/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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Official Journal |
EN L series |
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2025/2108 |
6.11.2025 |
DECISION OF THE EEA JOINT COMMITTEE No 172/2025
of 11 July 2025
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/2108]
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof,
Whereas:
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(1) |
Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (1) is to be incorporated into the EEA Agreement. |
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(2) |
Annex II to the EEA Agreement should therefore be amended accordingly, |
HAS ADOPTED THIS DECISION:
Article 1
The following indent is added in points 11 (Regulation (EU) 2017/745 of the European Parliament and of the Council) and 12 (Regulation (EU) 2017/746 of the European Parliament and of the Council) of Chapter XXX of Annex II to the EEA Agreement:
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‘— |
32024 R 1860: Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 (OJ L, 2024/1860, 9.7.2024).’ |
Article 2
The text of Regulation (EU) 2024/1860 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Article 3
This Decision shall enter into force on 12 July 2025, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).
Article 4
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
Done at Brussels, 11 July 2025.
For the EEA Joint Committee
The President
Kristján Andri STEFÁNSSON
(1) OJ L, 2024/1860, 9.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1860/oj.
(*1) Constitutional requirements indicated.
ELI: http://data.europa.eu/eli/dec/2025/2108/oj
ISSN 1977-0677 (electronic edition)