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Document 32011D0869

    2011/869/EU: Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) Text with EEA relevance

    OJ L 341, 22.12.2011, p. 63–64 (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/2011/869/oj

    Date of document:
    20/12/2011
    Date of effect:
    21/12/2011; Takes effect Date notif.
    Date of effect:
    01/07/2012; Application See Art 2
    Date of notification:
    21/12/2011
    Date of end of validity:
    No end date
    Author:
    European Commission
    Responsible body:
    Directorate-General for Health and Food Safety
    Form:
    Decision
    Addressee:
    The twenty-seven Member States: Belgium, Bulgaria, Czech Republic, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden, United Kingdom
    Additional information:
    EEA relevance
    Treaty:
    Treaty on the Functioning of the European Union
    Legal basis:
    Link
    Link
    Link
    Select all documents mentioning this document
    Modifies:
    Relation Act Comment Subdivision concerned From To
    Modifies 32002D0364 Amendment annex 01/07/2012
    Instruments cited:
    Link

    22.12.2011   

    EN

    Official Journal of the European Union

    L 341/63

    COMMISSION DECISION

    of 20 December 2011

    amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices

    (notified under document C(2011) 9398)

    (Text with EEA relevance)

    (2011/869/EU)

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (1), and in particular the second subparagraph of Article 5(3) thereof,

    Whereas:

    (1)

    The common technical specifications for in vitro diagnostic medical devices are laid down in Commission Decision 2002/364/EC (2).

    (2)

    In the interest of public health it is appropriate, where possible, to draw up common technical specifications for the devices listed in List A of Annex II to Directive 98/79/EC.

    (3)

    Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation have been added to List A of Annex II to Directive 98/79/EC by Commission Directive 2011/100/EU (3).

    (4)

    Taking into account the state of the art and the current scientific knowledge on Variant Creutzfeldt-Jakob disease, common technical specifications can be drawn up for vCJD blood screening assays.

    (5)

    The measures provided for in this Decision are in accordance with the opinion of the committee set up by Article 6(2) of Council Directive 90/385/EEC (4) and referred to in Article 7(1) of Directive 98/79/EC,

    HAS ADOPTED THIS DECISION:

    Article 1

    The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.

    Article 2

    This Decision shall apply from 1st of July 2012.

    However, Member States shall allow manufacturers to apply the requirements set out in the Annex before the date set out in the first paragraph of this Article.

    Article 3

    This Decision is addressed to the Member States.

    Done at Brussels, 20 December 2011.

    For the Commission

    John DALLI

    Member of the Commission

    (1)   OJ L 331, 7.12.1998, p. 1.

    (2)   OJ L 131, 16.5.2002, p. 17.

    (3)  See page 50 of this Official Journal.

    (4)   OJ L 189, 20.7.1990, p. 17.

    ANNEX

    1.   

    The following section is added at the end of Section 3 of the Annex to Decision 2002/364/EC:

    ‘3.7.   CTS for Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening

    CTS for Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening are set out in Table 11’

    2.   

    The following table is added at the end of the Annex to Decision 2002/364/EC:

    ‘Table 11

    Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening

     

    Material

    Number of specimens

    Acceptance Criteria

    Analytical sensitivity

    vCJD brain spikes in human plasma (WHO reference number NHBY0/0003)

    24 replicates of each of three dilutions of the material WHO number NHBY0/0003

    (1×104, 1×105, 1×106)

    23 of the 24 replicates detected at

    1×104

    vCJD spleen spikes in human plasma (10 % spleen homogenate — NIBSC reference number NHSY0/0009)

    24 replicates of each of three dilutions of the material NIBSC number NHSY0/0009

    (1×10, 1×102, 1×103)

    23 of the 24 replicates detected at

    1×10

    Diagnostic sensitivity

    A)

    Specimen from appropriate animal models

    As many specimen as reasonably possible and available, and at least 10 specimens

    90  %

    B)

    Specimen from humans with known clinical vCJD

    As many specimen as reasonably possible and available, and at least 10 specimens

    90  %

    Only in case where 10 specimens are not available:

    —

    the number of specimens tested shall be comprised between 6 and 9

    —

    all available specimens shall be tested

    no more than one false negative result

    Analytical specificity

    Potentially cross-reacting blood-specimens

    100

     

    Diagnostic specificity

    Normal human plasma samples from area of low BSE exposure

    5 000

    At least 99,5 %’
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