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    NB-MED - 2.1 - Rec - 1-2010 Representative Sample

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    Ivan Popovic
    This document provides recommendations on the definition of a "representative sample" for EC type examination of medical devices. It states that a representative sample is any one product manufactured according to the documentation submitted. The document has gone through several revisions to update terminology and align with new directives on medical devices and in vitro diagnostic medical devices. It was last approved by the NB-MED plenary in June 2000.

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    NB-MED - 2.1 - Rec - 1-2010 Representative Sample

    Uploaded by

    Ivan Popovic
    52 views3 pages
    This document provides recommendations on the definition of a "representative sample" for EC type examination of medical devices. It states that a representative sample is any one product manufactured according to the documentation submitted. The document has gone through several revisions to update terminology and align with new directives on medical devices and in vitro diagnostic medical devices. It was last approved by the NB-MED plenary in June 2000.

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    NB-MED_2.1_rec_1-2010 Representative Sample

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    This document provides recommendations on the definition of a "representative sample" for EC type examination of medical devices. It states that a representative sample is any one product manufactured according to the documentation submitted. The document has gone through several revisions to update terminology and align with new directives on medical devices and in vitro diagnostic medical devices. It was last approved by the NB-MED plenary in June 2000.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    52 views3 pages

    NB-MED - 2.1 - Rec - 1-2010 Representative Sample

    Uploaded by

    Ivan Popovic
    This document provides recommendations on the definition of a "representative sample" for EC type examination of medical devices. It states that a representative sample is any one product manufactured according to the documentation submitted. The document has gone through several revisions to update terminology and align with new directives on medical devices and in vitro diagnostic medical devices. It was last approved by the NB-MED plenary in June 2000.

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    Co-ordination of

    Notified Bodies Medical Devices


    Recommendation
    (NB-MED)
    on Council Directives 90/385/EEC, NB-MED/2.1/Rec1
    93/42/EEC and 98/79/EC

    Title: Representative Sample

    Chapter: 2.1 Scope, field of application, explanation of terms

    Text: ---
    Key words: sample

    A "representative sample" of production for EC type examination is any one product


    manufactured according to the documentation delivered.

    A rationale and history sheet is available; please contact Technical Secretariat.

    Reference to Article/ Reference to standards:


    Directives: Annex:
    AIMD Annex: 3-1
    MDD Annex: III-1
    IVDD Annex: V-1, VI-1, VI-4 prENxxx “Sampling procedures
    used for acceptance testing of
    in vitro diagnostic medical
    devices”

    Stage proposed by Rev.-Nr. Rev. date accepted amended withdrawn Page


    3 4 03.02.2000 06.06.2000 1/1

    VdTÜV G. Hinrich Schaub (- 178) Phone: ++49/201/8987- 0


    Technical Secretariat NB-MED Jörg Höppner (- 138) Fax: ++49/201/8987- 120
    PO Box 10 38 34 Kurfürstenstraße 56 eMail: [email protected]
    D-45038 Essen D-45138 Essen
    vdtuev-file: ...\hoeppner\mp\nb\rec_vdt2\R2_1-1_rev4.doc
    Rationale and
    Co-ordination of
    Notified Bodies Medical Devices
    history sheet
    (NB-MED) to
    on Council Directives 90/385/EEC, NB-MED/2.1/Rec1
    93/42/EEC and 98/79/EC

    Title: Representative Sample

    Rev. 2: Notified Body Meeting, Brussels, September. 24 & 25. 1996:


    The document was approved by the NB-MED plenary.
    Confirmed at stage 3.
    New revision no: 2

    Rev. 3: Meeting of NBR Group, Brussels, November 7, 1996:


    The NBRG has brought the document into the format of a NB-MED recommen-
    dation and issued it among their „stage 3“-recommendations. Some minor
    changes were done.
    Confirmed at stage 3.
    New revision no: 3

    Medical Devices Expert Group Meeting, Brussels, February 9 & 10, 1998:
    The stage 3 document was presented to the Medical Devices Experts Group and
    accepted without changes:
    Confirmed at stage 4.

    Rev. 4: Notified Body Meeting, Brussels, November, 2 & 3, 1999:


    The NBRG was asked to rework the NB-MED Recommendations in light of the
    IVD-directive.

    Meeting of NBR Group, Cologne, February 3, 2000:


    The work results of a small task force (task: reworking the Recommendations)
    were presented to that NBRG-meeting.
    The tabled revised Recommendation was discussed and NBRG agreed that the
    document, as discussed and revised, should be presented for adoption at the
    February/March NB-MED Plenary meeting. Only some editorial changes were
    made.
    Revision no: 4
    stage 2

    Notified Body Meeting, Brussels, February 29, & March 1, 2000:


    Dr. Holland reported that the current and valid/accepted stage 4 document (see
    NBM/123/99) was in the meanwhile revised by the NBRG/IVD task force (see
    NBM/35/00). Changes were made in light of the IVDD. Some comments have
    arrived and there is a need for incorporation those. The NB-MED agreed that
    further development on this Recommendation will be made within NBRG. A
    revised draft document should be presented at the next plenary (IVDD) meeting
    in June. Up to there the already accepted stage 3 document will be kept still
    valid.
    Revision no: 4
    stage 2

    Rev.-Nr. Rev. date accepted amended withdrawn Page


    06.06.2000 1/2

    VdTÜV G. Hinrich Schaub (- 178) Phone: ++49/201/8987- 0


    Technical Secretariat NB-MED Jörg Höppner (- 138) Fax: ++49/201/8987- 120
    PO Box 10 38 34 Kurfürstenstraße 56 eMail: [email protected]
    D-45038 Essen D-45138 Essen
    vdtuev-file: ...\hoeppner\mp\nb\rec_vdt2\R2_1-1_rev4.doc
    Rationale and
    Co-ordination of
    Notified Bodies Medical Devices
    history sheet
    (NB-MED) to
    on Council Directives 90/385/EEC, NB-MED/2.1/Rec1
    93/42/EEC and 98/79/EC

    Meeting of NBR Group, Brussels, April 10 &11, 2000:


    The document was once again accepted by NBRG in the same form as already
    presented to the last plenary meeting in March. NBRG agreed that the
    document, should be presented for adoption at the June NB-MED Plenary
    meeting.
    Revision no: 4
    stage 2

    Notified Body Meeting, Brussels, June 6 & 7, 2000:


    The document (NBM/56/00) was approved by the NB-MED plenary.
    Confirmed at stage 3.
    Revision no: 4

    Page
    2/2

    vdtuev-document dn: ...\hoeppner\mp\nb\rec_vdt2\R2_1-1_rev4.doc

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