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The European Association Medical devices - Notified Bodies - www.Team-NB.org
Medical DeviceSurvey2013
data from 28 NBs
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Total Average -
5,000
10,000
15,000
20,000
25,000
21,460
766
Valid certificates issued end of 2013
Numbers of certificate by 28 NBs> 1 000: 7 NBs200 - 1 000: 14 NBs< 200: 7 NBs
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Total Average0
5000
10000
15000
20000
25000
13889
817
21530
769
21460
766
Valid certificates issued 2010-2012-2013
2010 (19 NBs)2012 (28 NBs)2013 (28 NBs)
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Distribution between different directives
AIMDD4%
MDD90%
IVD6%
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Distribution between different conformity assessment modules under AIMDD
Annex 2 80%
Annex 312%
Annex 45%
Annex 53%
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Distribution between different conformity assessment modules under MDD
Annex 247%Annex 5
24%
Annex 61%
Annex 44%
Annex 31%
Annex 2 including EC design examina-
tion20%
EC design examina-tion including com-
bination product1%
* ECDE: EC Design Examination- EC design examination with drug consultation: answers from 10 NBs.
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Distribution between different conformity assessment modules under IVDD
Annex 329%
Annex 4 67%
Annex 73.89%
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New certificates issued in 2013
Total Average -
1,000
2,000
3,000
4,000
5,000
6,000
5,061
181
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New certificates issued : 2010 – 2012 - 2013
Total Average0
1000
2000
3000
4000
5000
6000
7000
8000
6993
411
3120
111
5061
181
2010
2012
2013
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Distribution between different directives in 2013
AIMDD3%
MDD87%
IVD11%
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Distribution between different conformity assessment modules under AIMDD in 2013
Annex 2 85%
Annex 32%
Annex 48%
Annex 5
5%
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Distribution between different conformity assessment modules under MDD in 2013
Annex 251%Annex 5
27%Annex 6
2%
Annex 41%
Annex 32%
EC design exam-ination
16%
EC design examination with drug consultation
1%
EC design examination with drug consultation for
initial certification1%
EC design examinationwith drug consultation: answers from 13 NBs.
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Distribution between different conformity assessment modules under IVDD in 2013
Annex 325%
Annex 4 70%
Annex 75%
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Valid certificates against ISO 13485
Series1 -
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000 16,946
605
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Valid certificates against ISO 13485 : 2010 – 2012 - 2013
Total Average0
2000
4000
6000
8000
10000
12000
14000
16000
18000
20000
11695
688
18734
669
16946
605
2010 (19 NBs)
2012 (28 NBs)
2013 (28 NBs)
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Number of certificates withdrawn in 2013
Series1 -
100
200
300
400
500
600
700
800
900
1,000 881
31
Reasons for withdrawing:- Clients cancellations- Non compliances- Refusal to have an audit- Not adapted to require-ments of MDD annex X- Major non-conformities- Acquisition by larger organization- Stop of activities
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Number of certificates withdrawn in 2010 – 2012 - 2013
Total Average 0
100
200
300
400
500
600
700
800
900
1000
244
14
915
33
881
31
2010
2012
2013
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Certification Holders
Worldwide (outside EU)
65%
EU35%
Total certification holdersestimated to 21 450 / 28 NBs
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Staff in 2013 (full time equivalent in MD sector)
Total Average -
200
400
600
800
1,000
1,200
1,400 1,291
46
739
26
FTE employee
FTE subcontractors
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Staff (full time equivalent in MD sector):2010 – 2012 - 2013
Total Average Total AverageFTE employee FTE subcontractors
-
200
400
600
800
1,000
1,200
1,400
1,600
770
45
310
18
1,383
49
785
28
1291
46
739
26
201020122013
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Total personnel capacity in 2013 (by NBs size)
>1000 200-1000 <200 -
200
400
600
800
1,000
1,200
1,400 1,292
604
134 185
43 19 51 16 11
481
11348
Total
Average
Min
Max
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Medical Device Survey 2013
In case of any further clarification needed, please contact [email protected]
Administrative Committee
President : Gert Bos
Vice President : Hans-Heiner Junker
Assistant Vice President : Guy Buijzen
Treasurer: Aud Løken Eiklid
Secretary: Corinne Delorme
Director: Françoise Schlemmer
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Medical Device Survey 2013
TEAM-NB: Members
