DECISION OF THE EEA JOINT COMMITTEE No 48/2023

of 17 March 2023

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2331]

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) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices ( 1 ) is to be incorporated into the EEA Agreement.

(2) Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose ( 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 11c (Commission Implementing Regulation (EU) 2021/2078) of Chapter XXX of Annex II to the EEA Agreement:

‘11d.

32022 R 2346 : Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices ( OJ L 311, 2.12.2022, p. 60 ).

11e.

32022 R 2347 : Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose ( OJ L 311, 2.12.2022, p. 94 ).’

Article 2

The texts of Implementing Regulations (EU) 2022/2346 and (EU) 2022/2347 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 311, 2.12.2022, p. 60 .

( 2 ) OJ L 311, 2.12.2022, p. 94 .

( *1 ) No constitutional requirements indicated.

ELI: http://data.europa.eu/eli/dec/2023/2331/oj

ISSN 1977-0677 (electronic edition)