1 / 21

Medical Device Survey 2012 Data Distribution Analysis

Explore distribution trends of Medical Device Directives 2010, including MDD, IVD, AIMDD. Detailed breakdown of conformity assessment modules. Insights on certificates issued, withdrawn, ISO 13485 validity, and staff statistics.

pier
Télécharger la présentation

Medical Device Survey 2012 Data Distribution Analysis

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related