DECISION OF THE EEA JOINT COMMITTEE No 134/2022

of 29 April 2022

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1578]

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) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices ( 1 ) is to be incorporated into the EEA Agreement.

(2)

Implementing Regulation (EU) 2021/2226 repeals Commission Regulation (EU) No 207/2012 ( 2 ) , which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.

(3)

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

HAS ADOPTED THIS DECISION:

Article 1

Chapter XXX of Annex II to the EEA Agreement shall be amended as follows:

(1)

the text of point 9 (Commission Regulation (EU) No 207/2012) is deleted;

(2)

the following point is inserted after point 11a (Commission Implementing Decision (EU) 2019/1396):

‘11b.

32021 R 2226 : Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices ( OJ L 448, 15.12.2021, p. 32 ).’.

Article 2

The text of Implementing Regulation (EU) 2021/2226 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 30 April 2022, provided that all the notifications under Article 103(1) of the EEA Agreement have been made ( 3 ) .

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, 29 April 2022.

For the EEA Joint Committee

The President

Nicolas VON LINGEN

( 1 ) OJ L 448, 15.12.2021, p. 32 .

( 2 ) OJ L 72, 10.3.2012, p. 28 .

( 3 ) No constitutional requirements indicated.