See Full Document Text
Official Journal EN
of the European Union L series
2026/1263 25.6.2026
DECISION OF THE EEA JOINT COMMITTEENo 71/2026
of 20 March 2026
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2026/1263]
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) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation
(EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the
Member State Coordination Group on Health Technology Assessment and the Commission with the European
Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal
products and medical devices and in vitrodiagnostic medical devices and as regards the joint scientific consultation
on medicinal products and 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 point is inserted after point 23b (Commission Implementing Regulation (EU) 2025/117) of Chapter XIII of
Annex II to the EEA Agreement:
‘23c. 32024 R 2699: Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down,
pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules
for the cooperation of the Member State Coordination Group on Health Technology Assessment and the
Commission with the European Medicines Agency in the form of exchange of information as regards the joint
clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as
regards the joint scientific consultation on medicinal products and medical devices (OJ L, 2024/2699,
21.10.2024).’
Article 2
The following point is inserted after point 17b (Commission Implementing Regulation (EU) 2025/117) of Chapter XXX of
Annex II to the EEA Agreement:
‘17c. 32024 R 2699: Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down,
pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules
for the cooperation of the Member State Coordination Group on Health Technology Assessment and the
Commission with the European Medicines Agency in the form of exchange of information as regards the joint
clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as
regards the joint scientific consultation on medicinal products and medical devices (OJ L, 2024/2699,
21.10.2024).’
Article 3
The text of Implementing Regulation (EU) 2024/2699 in the Icelandic and Norwegian languages, to be published in the
EEA Supplement to the Official Journal of the European Union, shall be authentic.
(1) OJ L, 2024/2699, 21.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2699/oj.
ELI: http://data.europa.eu/eli/dec/2026/1263/oj 1/2EN
OJ L, 25.6.2026
Article 4
This Decision shall enter into force on 21 March 2026, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made(*).
Article 5
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, 20 March 2026.
For the EEA Joint Committee
The President
Nicolas VON LINGEN
(*) No constitutional requirements indicated.
2/2 ELI: http://data.europa.eu/eli/dec/2026/1263/oj