Date: 2023-03-16Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 90/2020 of 18 June 2020 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/539]
**Summary:**
EEA Joint Committee Decision No. 90/2020, adopted on June 18, 2020, amends Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement. This decision incorporates Regulation (EU) 2020/561 of the European Parliament and of the Council of April 23, 2020, into the EEA Agreement. Regulation (EU) 2020/561 modifies Regulation (EU) 2017/745 on medical devices, specifically concerning the application dates of certain provisions. The amendment is detailed in Article 1, which adds Regulation (EU) 2017/745, as amended by 32020 R 0561 (Regulation (EU) 2020/561, OJ L 130, 24.4.2020, p. 18), to Chapter XXX of Annex II. The authentic Icelandic and Norwegian language texts of Regulation (EU) 2020/561 will be published in the EEA Supplement to the Official Journal of the European Union (OJ). The decision entered into force on June 18, 2020, contingent upon completion of notifications under Article 103(1) of the EEA Agreement, or the entry into force of Decision of the EEA Joint Committee No 288/2019 of 13 December 2019, whichever is later. The Decision will be 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: Agreement on the European Economic Area
Regulation (EU) 2017/745: Regulation on medical devices.
Regulation (EU) 2020/561: Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices.
European Parliament: Legislative branch of the European Union
Council of the European Union: A legislative body of the European Union comprising government ministers from each member state
Brussels: City in Belgium where the decision was made.
Clara GANSLANDT: The President of the EEA Joint Committee.
L 78/40 EN Official Journal of the European Union 16.3.2023
DECISION OF THE EEA JOINT COMMITTEE No 90/2020
of 18 June 2020
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2023/539]
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) Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020amending Regulation
(EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions(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 is added in point 11 (Regulation (EU) 2017/745 of the European Parliament and of the Council) of Chapter
XXX of Annex II to the EEA Agreement:
‘, as amended by:
— 32020 R 0561: Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020(OJ L 130,
24.4.2020, p. 18).’
Article 2
The text of Regulation (EU) 2020/561 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 18 June 2020, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made*, or on the day of the entry into force of Decision of the EEA Joint Committee No 288/2019
of 13 December 2019(2), whichever is the later.
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, 18 June 2020.
For the EEA Joint Committee
The President
Clara GANSLANDT
(1) OJ L 130, 24.4.2020, p. 18.
(*) No constitutional requirements indicated.
(2) OJ L 68, 5.3.2020, p. 24.