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Document 22012D0164

    Decision of the EEA Joint Committee No 164/2012 of 28 September 2012 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

    OJ L 341, 13.12.2012, p. 15–15 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵This document has been published in a special edition(s) (HR)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/dec/2012/164(2)/oj

    Date of document:
    28/09/2012
    Date of effect:
    01/11/2012; Entry into force See Art 3
    Date of end of validity:
    No end date
    Author:
    EEA Joint Committee
    Form:
    Decision adopted by bodies created by international agreements
    Treaty:
    Agreement on the European Economic Area
    Legal basis:
    Link
    Link
    Link
    Select all documents mentioning this document
    Modifies:
    Relation Act Comment Subdivision concerned From To
    Modifies 21994A0103(52) Repeal chapter XXX point 3 indent 1 01/11/2012
    Modifies 21994A0103(52) Addition chapter XXX point 2 Text 01/11/2012
    Modifies 21994A0103(52) Addition chapter XXX point 3 indent 01/11/2012
    Instruments cited:
    Link

    13.12.2012   

    EN

    Official Journal of the European Union

    L 341/15

    DECISION OF THE EEA JOINT COMMITTEE

    No 164/2012

    of 28 September 2012

    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 (‘the EEA Agreement’), and in particular Article 98 thereof,

    Whereas:

    (1)

    Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (1) is to be incorporated into the EEA Agreement.

    (2)

    Commission Decision 2009/886/EC of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (2), as corrected by OJ L 348, 29.12.2009, p. 94, is to be incorporated into the EEA Agreement.

    (3)

    Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (3) is to be incorporated into the EEA Agreement.

    (4)

    Decision 2009/886/EC repeals Commission Decision 2009/108/EC (4) which is incorporated into the Agreement and which is consequently to be repealed under the EEA Agreement.

    (5)

    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 following shall be added in point 2 (Directive 98/79/EC of the European Parliament and of the Council):

    ‘, as amended by:

    —

    32011 L 0100: Commission Directive 2011/100/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 50).’;

    (2)

    the first indent in point 3 (Commission Decision 2002/364/EC) shall be deleted;

    (3)

    the following indents shall be added in point 3 (Commission Decision 2002/364/EC):

    ‘—

    32009 D 0886: Commission Decision 2009/886/EC of 27 November 2009 (OJ L 318, 4.12.2009, p. 25), as corrected by OJ L 348, 29.12.2009, p. 94,

    —

    32011 D 0869: Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 63).’.

    Article 2

    The texts of Directive 2011/100/EU, Decision 2009/886/EC, as corrected by OJ L 348, 29.12.2009, p. 94, and Decision 2011/869/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 1 November 2012, provided that all the notifications under Article 103(1) of the EEA Agreement have been made to the EEA Joint Committee (*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, 28 September 2012.

    For the EEA Joint Committee

    The President

    Atle LEIKVOLL

    (1)   OJ L 341, 22.12.2011, p. 50.

    (2)   OJ L 318, 4.12.2009, p. 25.

    (3)   OJ L 341, 22.12.2012, p. 63.

    (4)   OJ L 39, 10.2.2009, p. 34.

    (*1)  No constitutional requirements indicated.

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