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Medical Device Survey 2012 data from 28 NBs

Medical Device Survey 2012 data from 28 NBs. Distribution between different directives. 2010 MDD : 93% IVD : 5% AIMDD : 2%. Distribution between different conformity assessment modules under AIMDD. 2010 : data from 5 NBs Annex 2 : 74% Annex 3 : 17% Annex 4 : 3%

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Medical Device Survey 2012 data from 28 NBs

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  1. Medical DeviceSurvey2012data from 28 NBs

  2. www.Team-NB.org

  3. www.Team-NB.org

  4. Distribution betweendifferent directives 2010 MDD : 93% IVD : 5% AIMDD : 2% www.Team-NB.org

  5. Distribution betweendifferentconformityassessment modules under AIMDD 2010 : data from 5 NBs Annex 2 : 74% Annex 3 : 17% Annex 4 : 3% Annex 5 : 6% www.Team-NB.org

  6. Distribution betweendifferentconformityassessment modules under MDD 2010 (1) : 1% (7 NBs) (2) : 18% Annex 2 : 41% Annex 3 : 2% Annex 4 : 6% Annex 5 : 27% Annex 6 : 1% * ECDE: EC Design Examination - EC design examinationwithdrug consultation: answersfrom 10 NBs. www.Team-NB.org

  7. Distribution betweendifferentconformityassessment modules under IVDD 2010 : 8 NBs Annex 3 : 25% Annex 4 : 50% Annex 7 : 25% www.Team-NB.org

  8. New certificates issued in 2012 www.Team-NB.org

  9. New certificates issued : 2010 - 2012 www.Team-NB.org

  10. Distribution betweendifferent directives in 2012 2010 MDD : 91% IVD : 6% AIMDD : 3% www.Team-NB.org

  11. Distribution betweendifferentconformityassessment modules under AIMDD in 2012 2010 : data from 5 NBs Annex 2 : 83% Annex 3 : 15% Annex 4 : 0,1% Annex 5 : 2% www.Team-NB.org

  12. Distribution betweendifferentconformityassessment modules under MDD in 2012 2010 (1) : 1% (2) : 1% (3) : 23% Annex 2 : 45% Annex 3 : 3% Annex 4 : 1% Annex 5 : 25% Annex 6 : 1% EC design examination withdrug consultation: answersfrom 13NBs. www.Team-NB.org

  13. Distribution betweendifferentconformityassessment modules under IVDD in 2012 2010 Annex 3 : 13% Annex 4 : 75% Annex 7 : 12% www.Team-NB.org

  14. Valid certificates against ISO 13485 www.Team-NB.org

  15. Valid certificates against ISO 13485 : 2010 - 2012 www.Team-NB.org

  16. Number of certificates withdrawn in 2012 www.Team-NB.org

  17. Number of certificates withdrawn in 2010 - 2012 www.Team-NB.org

  18. Certification Holders 2010 EU : 37% Outside EU : 63% Total holders : 21247 / 17 NBs www.Team-NB.org

  19. Staff in 2012 (full time equivalent in MD sector) www.Team-NB.org

  20. Staff (full time equivalent in MD sector) : 2010 - 2012 www.Team-NB.org

  21. Full Time employee in 2012 (by NBs size) www.Team-NB.org

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