Decision of the EEA Joint Committee No 198/2025 of 19 September 2025 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/6]
Date: 2025-09-19
Institutions: EEA Joint Committee
Subjects: European Economic Area, clinical trial, exchange of information, health care, health technology, innovation, medical device, medical diagnosis, public health, revision of an agreement, scientific cooperation




L_202600006EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/6


15.1.2026







            DECISION OF THE EEA JOINT COMMITTEE No 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 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
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 vitro diagnostic 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 vitro diagnostic 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).


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
            





(1)  
            OJ L, 2025/117, 27.1.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/117/oj.

(*1)  No constitutional requirements indicated.


ELI: http://data.europa.eu/eli/dec/2026/6/oj
ISSN 1977-0677 (electronic edition)