This document is an excerpt from the EUR-Lex website
Document 22026D1486
Decision of the EEA Joint Committee No 131/2026 of 30 April 2026 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/1486]
Decision of the EEA Joint Committee No 131/2026 of 30 April 2026 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/1486]
Decision of the EEA Joint Committee No 131/2026 of 30 April 2026 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/1486]
OJ L, 2026/1486, 23.7.2026, ELI: http://data.europa.eu/eli/dec/2026/1486/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
|
Official Journal |
EN L series |
|
2026/1486 |
23.7.2026 |
DECISION OF THE EEA JOINT COMMITTEE No 131/2026
of 30 April 2026
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/1486]
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) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments (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 23e (Commission Implementing Regulation (EU) 2024/3169) of Chapter XIII:
|
|
2. |
The following point is inserted after point 17d (Commission Implementing Regulation (EU) 2024/2745) of Chapter XXX:
|
Article 2
The text of Implementing Regulation (EU) 2025/2086 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 1 May 2026, 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, 30 April 2026.
For the EEA Joint Committee
The President
Nicolas VON LINGEN
(1) OJ L, 2025/2086, 20.10.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj.
(*1) No constitutional requirements indicated.
ELI: http://data.europa.eu/eli/dec/2026/1486/oj
ISSN 1977-0677 (electronic edition)