DECISION OF THE EEA JOINT COMMITTEE

No 131/2011

of 2 December 2011

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area, as amended by the Protocol adjusting the Agreement on the European Economic Area, hereinafter referred to as ‘the Agreement’, and in particular Article 98 thereof,

Whereas:

(1) Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 139/2009 of 4 December 2009(1).

(2) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed)(2) is to be incorporated into the Agreement,

HAS ADOPTED THIS DECISION:

Article 1

The following shall be inserted after point 7 (Council Directive 90/385/EEC) of Chapter XXX of Annex II to the Agreement:

‘8.

32010 D 0227

: Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (

OJ L 102, 23.4.2010, p. 45

).’.

Article 2

The text of Decision 2010/227/EU 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 3 December 2011, provided that all the notifications pursuant to Article 103(1) of the Agreement have been made to the EEA Joint Committee(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, 2 December 2011.

For the EEA Joint Committee

The President

Kurt JÄGER

(1)

OJ L 62, 11.3.2010, p. 33

(2)

OJ L 102, 23.4.2010, p. 45

(3) No constitutional requirements indicated.