1. The European Association Medical devices - Notified Bodies - www.Team-NB.org Medical Device Survey 2012 data from 28 NBs

2. 2 www.Team-NB.org

3. 3

4. 4 Distribution between different directives 2010 MDD : 93% IVD :5% AIMDD : 2%

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

6. 6 www.Team-NB.org Distribution between different conformity assessment modules under MDD * ECDE: EC Design Examination - EC design examination with drug consultation: answers from 10 NBs. 2010 (1) :1% (7 NBs) (2) : 18% Annex 2 :41% Annex 3 :2% Annex 4 : 6% Annex 5 :27% Annex 6 : 1%

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

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

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

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

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

12. 12 www.Team-NB.org Distribution between different conformity assessment modules under MDD in 2012 EC design examination with drug consultation: answers from 13 NBs. 2010 (1) :1% (2) : 1% (3) : 23% Annex 2 :45% Annex 3 :3% Annex 4 : 1% Annex 5 :25% Annex 6 : 1%

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

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

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

16. 16 www.Team-NB.org Number of certificates withdrawn in 2012

17. 17 www.Team-NB.org Number of certificates withdrawn in 2010 - 2012

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

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

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

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