The European Association Medical devices - Notified Bodies - Medical Device Survey 2012 data from 28 NBs

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

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

7 Distribution between different conformity assessment modules under IVDD 2010 : 8 NBs Annex 3 :25% Annex 4 : 50% Annex 7 : 25%

8 New certificates issued in 2012

9 New certificates issued :

10 Distribution between different directives in MDD : 91% IVD :6% AIMDD : 3%

11 Distribution between different conformity assessment modules under AIMDD in : data from 5 NBs Annex 2 : 83% Annex 3 :15% Annex 4 : 0,1% Annex 5 : 2%

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

13 Distribution between different conformity assessment modules under IVDD in Annex 3 :13% Annex 4 : 75% Annex 7 : 12%

14 Valid certificates against ISO 13485

15 Valid certificates against ISO :

16 Number of certificates withdrawn in 2012

17 Number of certificates withdrawn in

18 Certification Holders 2010 EU :37% Outside EU : 63% Total holders : / 17 NBs

19 Staff in 2012 (full time equivalent in MD sector)

20 Staff (full time equivalent in MD sector) :

21 Full Time employee in 2012 (by NBs size)