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 ( *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, 11 December 2020.

For the EEA Joint Committee

The President

Sabine MONAUNI

( 1 ) OJ L 149, 7.6.2019, p. 73 .

( *1 ) No constitutional requirements indicated.