Date: 2023-09-28Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 202/2020 of 11 December 2020 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2004]
**Summary:**
EEA Joint Committee Decision No. 202/2020, adopted on December 11, 2020, amends Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement. The amendment incorporates Commission Implementing Decision (EU) 2019/939 of June 6, 2019, which designates issuing entities authorized to operate a system for the assignment of Unique Device Identifiers (UDIs) for medical devices, into the EEA Agreement. This decision ensures the implementation of standardized device identification within the European Economic Area. The text of Implementing Decision (EU) 2019/939 will be published in Icelandic and Norwegian in the EEA Supplement to the Official Journal of the European Union and will be considered authentic. The decision entered into force on December 12, 2020, following the completion of notifications required under Article 103(1) of the EEA Agreement. The decision was published in the EEA Section of, and 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
Annex II to the EEA Agreement: Technical regulations, standards, testing and certification mentioned in the EEA agreement.
Commission Implementing Decision EU 2019/939: A decision designating issuing entities for Unique Device Identifiers (UDIs) for medical devices.
Unique Device Identifiers (UDIs): A system for the assignment of Unique Device Identifiers UDIs in the field of medical devices
Regulation EU 2017/746: Regulation of the European Parliament and of the Council of Chapter XXX of Annex II to the EEA Agreement
Brussels: The location where the decision was made.
Sabine MONAUNI: The President of the EEA Joint Committee.
L 240/54 EN Official Journal of the European Union 28.9.2023
DECISION OF THE EEA JOINT COMMITTEE No 202/2020
of 11 December 2020
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2023/2004]
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 Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to
operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of 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 12 (Regulation (EU) 2017/746 of the European Parliament and of the Council) of
Chapter XXX of Annex II to the EEA Agreement:
‘13. 32019 D 0939: Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities
designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
(OJ L 149, 7.6.2019, p. 73).’
Article 2
The text of Implementing Decision (EU) 2019/939 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 12 December 2020, provided that all the notifications under Article 103(1) of the
EEA Agreement have been made*.
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.
(1) OJ L 149, 7.6.2019, p. 73.
* No constitutional requirements indicated.28.9.2023 EN Official Journal of the European Union L 240/55
Done at Brussels, 11 December 2020.
For the EEA Joint Committee
The President
Sabine MONAUNI