DECISION OF THE EEA JOINT COMMITTEE No 144/2021

of 23 April 2021

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/143]

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) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council ( 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 13 (Commission Implementing Decision (EU) 2019/939) of Chapter XXX of Annex II to the EEA Agreement:

‘14.

32017 R 2185 : Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council ( OJ L 309, 24.11.2017, p. 7 ).’

Article 2

The text of Implementing Regulation (EU) 2017/2185 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 24 April 2021, 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, 23 April 2021.

For the EEA Joint Committee

The President

Clara GANSLANDT

( 1 ) OJ L 309, 24.11.2017, p. 7 .

( *1 ) No constitutional requirements indicated.

ELI: http://data.europa.eu/eli/dec/2024/143/oj

ISSN 1977-0677 (electronic edition)