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    2010/227/: Commission Decision of 19 April 2010 on the European Databank on Medic... (32010D0227)
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    EU - Rechtsakte: 13 Industrial policy and internal market
    When entering data in Eudamed, Member States may choose between on-line data entry and up-loading of XML files.
    Member States shall ensure that when entering data into Eudamed medical devices are described using a code from an internationally recognised nomenclature for medical devices.

    Article 5

    As concerns data existing before the date referred to in Article 6, Member States shall ensure that the data on registration of manufacturers, authorised representatives and devices are entered into Eudamed in accordance with Article 14a(1)(a) of Directive 93/42/EEC and Article 12(1)(a) of Directive 98/79/EC.
    That data shall be entered by 30 April 2012 at the latest.

    Article 6

    Member States shall apply this Decision from 1 May 2011.

    Article 7

    This Decision is addressed to the Member States.
    Done at Brussels, 19 April 2010.
    For the Commission
    John DALLI
    Member of the Commission
    (1)  
    OJ L 189, 20.7.1990, p. 17
    .
    (2)  
    OJ L 169, 12.7.1993, p. 1
    .
    (3)  
    OJ L 331, 7.12.1998, p. 1
    .
    (4)  
    OJ C 20, 24.1.2004, p. 1
    .
    (5)  
    OJ L 247, 21.9.2007, p. 21
    .

    ANNEX

    Table detailing the mandatory data fields in the respective module in the Eudamed databank according to the obligations arising from Directives 93/42/EEC, 90/385/EEC and 98/79/EC

    Directive 93/42/EEC

    Minimum data required for Eudamed data entry

    Article 14a(1)(a) and Article 14(1) and (2)

    1.

    Actor (manufacturer/authorised representative):

    (a)

    Name;

    (b)

    Street;

    (c)

    Locality;

    (d)

    Postcode;

    (e)

    Country;

    (f)

    Phone or E-mail;

    (g)

    Role.

    2.

    Device:

    (a)

    Internationally recognised nomenclature code (for data generated after 1 May 2011);

    (b)

    Device Name/Make or, where not available, generic name.

    Article 14a(1)(b)

    3.

    Certificate:

    (a)

    Certificate number;

    (b)

    Certificate type;

    (c)

    Date of Issue;

    (d)

    Expiration Date;

    (e)

    Manufacturer and, if applicable, authorised representative (see fields under 1. Actor);

    (f)

    Notified Body (selected from system);

    (g)

    General Scope description and, where applicable, details on device (see fields under 2. Device);

    (h)

    Status and, where applicable, reasons for decision of Notified Body.

    Article 14a(1)(c) and Article 10(3)

    4.

    Incident (National Competent Authority Report):

    (a)

    Competent Authority reference;

    (b)

    Manufacturer, where applicable authorised representative (see fields under 1. Actor);

    (c)

    Manufacturer contact;

    (d)

    Manufacturer reference/Field Safety Corrective Action (FSCA) nr.;

    (e)

    Device (see fields under 2. Device), plus where applicable lot number, serial number, software version;

    (f)

    Notified Body (selected from system);

    (g)

    Device known to be in the market in;

    (h)

    Confidential;

    (i)

    Complete investigation;

    (j)

    Background Information (Description);

    (k)

    Conclusion;

    (l)

    Recommendation;

    (m)

    Action and action description.

    Article 14a(1)(d) and Article 15(1), (6) and (7)

    5.

    Clinical Investigation:

    (a)

    Manufacturer, where applicable authorised representative (see fields under 1. Actor);

    (b)

    Device (see fields under 2. Device);

    (c)

    Title of investigation;

    (d)

    Protocol number;

    (e)

    Primary objective;

    (f)

    Competent Authority Contact for this Clinical Investigation;

    (g)

    Decisions taken by Competent Authority pursuant to Article 15(6), date of decision and grounds;

    (h)

    Early termination on safety grounds pursuant to Article 15(7), date of decision and grounds.

    Directive 90/385/EEC

    Minimum data required for Eudamed data entry

    Article 10b(1)(a)

    6.

    Certificate (see fields under 3. Certificate)

    Article 10b(1)(b) and Article 8(3)

    7.

    Incident (see fields under 4. Incident)

    Article 10b(1)(c) and Article 10(1), (3) and (4)

    8.

    Clinical Investigation (see fields under 5. Clinical Investigation, (a) to (f)):

    (a)

    Decisions taken by Competent Authority pursuant to Article 10(3), date of decision and grounds;

    (b)

    Early termination on safety grounds pursuant to Article 10(4), date of decision and grounds.

    Directive 98/79/EC

    Minimum data required for Eudamed data entry

    Article 12(1)(a) and Article 10(1), (3) and (4) and Annex VIII (4)

    9.

    Actor (for all in vitro diagnostic medical devices (IVD’s):

    Address of manufacturer, respectively authorised representative (see fields under 1. Actor).

    10.

    Device:

    For all IVD’s

    (a)

    Device (see fields under Device 2.);

    (b)

    Information on whether device is ‘new’;

    (c)

    Discontinuation of placing on the market.

    In addition for Annex II and self-testing

    (d)

    Outcome of performance evaluation, where applicable;

    (e)

    Certificates (see fields under 3. Certificate);

    (f)

    Conformity with Common Technical Specifications, where applicable;

    (g)

    Identification of device.

    Article 12(1)(b)

    11.

    Certificate (see fields under 3. Certificate)

    Article 12(1)(c) and Article 11(3)

    12.

    Incident (see fields under 4. Incident)
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