DECISION OF THE EEA JOINT COMMITTEE No 49/2023

of 17 March 2023

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2338]

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) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices ( 1 ) is to be incorporated into the EEA Agreement.

(2) Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices ( 2 ) is to be incorporated into the EEA Agreement.

(3) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following points are inserted after point 12a (Commission Implementing Regulation (EU) 2022/1107) of Chapter XXX of Annex II to the EEA Agreement:

‘12b.

32022 R 0944 : Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices ( OJ L 164, 20.6.2022, p. 7 ).

12c.

32022 R 0945 : Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices ( OJ L 164, 20.6.2022, p. 20 ).’

Article 2

The texts of Implementing Regulations (EU) 2022/944 and (EU) 2022/945 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 March 2023, 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, 17 March 2023.

For the EEA Joint Committee

The President

Nicolas VON LINGEN

( 1 ) OJ L 164, 20.6.2022, p. 7 .

( 2 ) OJ L 164, 20.6.2022, p. 20 .

( *1 ) No constitutional requirements indicated.

ELI: http://data.europa.eu/eli/dec/2023/2338/oj

ISSN 1977-0677 (electronic edition)