Decision of the EEA Joint Committee

No 166/1999

of 26 November 1999

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 adjusted 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 No 7/94 of the EEA Joint Committee of 21 March 1994(1).

(2) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(2) is to be incorporated into the Agreement,

HAS DECIDED AS FOLLOWS:

Article 1

The following point shall be inserted after point 1 (Council Directive 93/42/EEC) in Chapter XXX of Annex II to the Agreement:

"2. 398 L 0079: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as corrected by OJ L 22, 29.1.1999, p. 75."

Article 2

1. The following indent shall be added in point 1 (Directive 98/37/EC of the European Parliament and of the Council) in Chapter XXIV of Annex II to the Agreement:

"- 398 L 0079: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 (OJ L 331, 7.12.1998, p. 1), as corrected by OJ L 22, 29.1.1999, p. 75."

2. The following shall be added in point 1 (Council Directive 93/42/EEC) in Chapter XXX of Annex II to the Agreement:

", as amended by:

- 398 L 0079: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 (OJ L 331, 7.12.1998, p. 1), as corrected by OJ L 22, 29.1.1999, p. 75."

Article 3

The texts of Directive 98/79/EC in the Icelandic and Norwegian languages which are annexed to the respective language versions of this Decision, are authentic.

Article 4

This Decision shall enter into force on 27 November 1999, provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee.

Article 5

This Decision shall be published in the EEA section of, and in the EEA Supplement to, the Official Journal of the European Communities.

Done at Brussels, 26 November 1999.

For the EEA Joint Committee

The President

N. v. Liechtenstein

(1) OJ L 160, 28.6.1994, p. 1.

(2) OJ L 331, 7.12.1998, p. 1.