Official Journal EN
of the European Union L series
2026/6 15.1.2026
DECISION OF THE EEA JOINT COMMITTEENo 198/2025
of 19 September 2025
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2026/6]
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article...
Official Journal EN of the European Union L series 2026/6 15.1.2026 DECISION OF THE EEA JOINT COMMITTEENo 198/2025 of 19 September 2025 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/6] 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) Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitrodiagnostic 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
Annex II to the EEA Agreement is amended as follows:
1. The following point is inserted after point 23a (Commission Implementing Regulation (EU) 2024/1381) of Chapter
XIII: ‘23b. 32025 R 0117: Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitrodiagnostic medical devices (OJ L, 2025/117, 27.1.2025).’
2. The following point is inserted after point 17a (Commission Implementing Regulation (EU) 2024/1381) of
Chapter XXX: ‘17b. 32025 R 0117: Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitrodiagnostic medical devices (OJ L, 2025/117, 27.1.2025).’ Article 2 The text of Implementing Regulation (EU) 2025/117 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 20 September 2025, provided that all the notifications under Article 103(1) of the EEA Agreement have been made(*).
(1) OJ L, 2025/117, 27.1.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/117/oj. (*) No constitutional requirements indicated.
ELI: http://data.europa.eu/eli/dec/2026/6/oj 1/2EN OJ L, 15.1.2026 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, 19 September 2025.
For the EEA Joint Committee The President Stefán Haukur JÓHANNESSON 2/2 ELI: http://data.europa.eu/eli/dec/2026/6/oj