Date: 2022-09-22Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 134/2022 of 29 April 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1578]
**Policy Summary:**
EEA Joint Committee Decision No. 134/2022, adopted on April 29, 2022, amends Annex II (Technical regulations, standards, testing and certification) to the Agreement on the European Economic Area (EEA). The decision incorporates Commission Implementing Regulation (EU) 2021/2226 into the EEA Agreement. This regulation lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council regarding electronic instructions for use (eIFU) of medical devices. Consequently, the decision also repeals Commission Regulation (EU) No 207/2012, which is already incorporated into the EEA Agreement and is superseded by Implementing Regulation (EU) 2021/2226. The amendment involves deleting point 9 of Chapter XXX of Annex II, which references Commission Regulation (EU) No 207/2012, and inserting a new point 11b referencing Commission Implementing Regulation (EU) 2021/2226 (OJ L 448, 15.12.2021, p. 32). The authentic Icelandic and Norwegian language texts of Implementing Regulation (EU) 2021/2226 will be published in the EEA Supplement to the Official Journal of the European Union. The decision entered into force on April 30, 2022, following notification under Article 103(1) of the EEA Agreement. The decision was published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
Key Entities Referenced
EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement.
EEA Agreement: The Agreement on the European Economic Area.
Annex II to the EEA Agreement: Annex containing technical regulations, standards, testing and certification.
Commission Implementing Regulation EU 2021/2226: A regulation laying down rules for the application of Regulation EU 2017/745 regarding electronic instructions for use of medical devices.
Regulation EU 2017/745: Regulation of the European Parliament and of the Council as regards electronic instructions for use of medical devices.
Commission Regulation EU No 207/2012: A commission regulation that is repealed by Implementing Regulation EU 2021/2226.
Brussels: Location where the decision was made.
Nicolas VON LINGEN: The President of the EEA Joint Committee.
22.9.2022 EN Official Journal of the European Union L 246/85
DECISION OF THE EEA JOINT COMMITTEE No 134/2022
of 29 April 2022
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2022/1578]
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) 2021/2226 of 14 December 2021laying down rules for the application
of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for
use of medical devices(1)is to be incorporated into the EEA Agreement.
(2) Implementing Regulation (EU) 2021/2226 repeals Commission Regulation (EU) No 207/2012(2), which is
incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.
(3) Annex II to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
Chapter XXX of Annex II to the EEA Agreement shall be amended as follows:
(1) the text of point 9 (Commission Regulation (EU) No 207/2012) is deleted;
(2) the following point is inserted after point 11a (Commission Implementing Decision (EU) 2019/1396):
‘11b. 32021 R 2226: Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down
rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards
electronic instructions for use of medical devices (OJ L 448, 15.12.2021, p. 32).’.
Article 2
The text of Implementing Regulation (EU) 2021/2226 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 30 April 2022, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made(3).
(1) OJ L 448, 15.12.2021, p. 32.
(2) OJ L 72, 10.3.2012, p. 28.
(3) No constitutional requirements indicated.L 246/86 EN Official Journal of the European Union 22.9.2022
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, 29 April 2022.
For the EEA Joint Committee
The President
Nicolas VON LINGEN