Date: 2025-11-06Category: Not ApplicableState: Union GovernmentCountry: Europe
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 Decision of the EEA Joint Committee No 172/2025, dated 11 July 2025, amends Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/2108]. It incorporates Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024, which amends Regulations (EU) 2017/745 and (EU) 2017/746 regarding 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, into the EEA Agreement by adding indent 32024 R 1860 to points 11 and 12 of Chapter XXX of Annex II to the EEA Agreement. The authentic texts of Regulation (EU) 2024/1860 in Icelandic and Norwegian will be published in the EEA Supplement to the Official Journal of the European Union. The decision enters into force on 12 July 2025, pending notifications under Article 103(1) of the EEA Agreement. The decision will be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union. The President of the EEA Joint Committee is Kristján Andri STEFÁNSSON.
Key Entities Referenced
Brussels: Location where the Decision was finalized.
EEA Agreement: Agreement on the European Economic Area; primary agreement being amended.
Regulation (EU) 2024/1860: Regulation of the European Parliament and of the Council being incorporated into the EEA Agreement.
EEA Joint Committee: Committee issuing the decision to amend the EEA Agreement.
Annex II: Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement is being amended.
Official Journal EN
of the European Union L series
2025/2108 6.11.2025
DECISION OF THE EEA JOINT COMMITTEENo 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:
(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.
(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:
‘— 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(*).
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.
(*) Constitutional requirements indicated.
ELI: http://data.europa.eu/eli/dec/2025/2108/oj 1/1