The European Association Medical devices - Notified Bodies - www.Team-NB.org
Medical DeviceSurvey2012
data from 28 NBs
2www.Team-NB.org
Total Average -
5,000
10,000
15,000
20,000
25,000
21,530
769
Valid certificates issued end of 2012
Numbers of certificate by 28 NBs
> 1 000 : 8 NBs
200 - 1 000 : 10 NBs
< 200 : 10 NBs
3www.Team-NB.org
Total Average0
5000
10000
15000
20000
25000
13889
817
21530
769
Valid certificates issued: 2010 - 2012
2010 (19 NBs)
2012 (28 NBs)
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AIMDD2%
MDD92%
IVD6%
Distribution between different directives
2010
MDD : 93%
IVD : 5%
AIMDD : 2%
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Annex 2 80%
Annex 316%
Annex 40.43%
Annex 53%
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%
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Annex 246%
Annex 524%
Annex 61%
Annex 44%
Annex 32%
(2) Annex 2 including EC design examina-
tion19%
(1) EC design examina-tion including combina-
tion product2%
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%
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Annex 337%
Annex 4 58%
Annex 75.37%
Distribution between different conformity assessment modules under IVDD
2010 : 8 NBs
Annex 3 : 25%
Annex 4 : 50%
Annex 7 : 25%
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Total Average -
500
1,000
1,500
2,000
2,500
3,000
3,500 3,120
111
New certificates issued in 2012
9www.Team-NB.org
Total Average0
1000
2000
3000
4000
5000
6000
7000
8000
2010
2012
New certificates issued : 2010 - 2012
10www.Team-NB.org
AIMDD7%
MDD84%
IVD9%
Distribution between different directives in 2012
2010
MDD : 91%
IVD : 6%
AIMDD : 3%
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Annex 2 70%
Annex 310%
Annex 41%
Annex 518%
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%
12www.Team-NB.org
Annex 245%
Annex 529%
Annex 65%
Annex 41%
Annex 32%
(3) EC design examina-tion8%
(2) EC design examina-tion with drug consulta-
tion7%
(1) EC design examination with drug consultation for ini-
tial certification3%
Distribution between different conformity assessment modules under MDD in 2012
EC design examinationwith 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%
13www.Team-NB.org
Annex 325%
Annex 4 58%
Annex 717%
Distribution between different conformity assessment modules under IVDD in 2012
2010
Annex 3 : 13%
Annex 4 : 75%
Annex 7 : 12%
14www.Team-NB.org
Total Average -
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
20,000 18,734
669
Valid certificates against ISO 13485
15www.Team-NB.org
Valid certificates against ISO 13485 : 2010 - 2012
Total Average0
2000
4000
6000
8000
10000
12000
14000
16000
18000
20000
2010 (19 NBs)
2012 (28 NBs)
16www.Team-NB.org
Total Average -
100 200 300 400 500 600 700 800 900
1,000 915
33
Reasons for withdrawing:- Clients cancellations- Non compliances- Refusal to have an audit- Not addapted to require-ments of MDD annex X- Major non-conformities- Acquisition by larger organization- Stop of activities
Number of certificates withdrawn in 2012
17www.Team-NB.org
Total Average 0
100
200
300
400
500
600
700
800
900
1000
2010
2012
Number of certificates withdrawn in 2010 - 2012
18www.Team-NB.org
Worldwide (outside EU)
63%
EU37%
Total certification holders estimated to 21 530 / 28 NBs
Certification Holders
2010
EU : 37%
Outside EU : 63%
Total holders : 21247 / 17 NBs
19www.Team-NB.org
Total Average -
200
400
600
800
1,000
1,200
1,400
1,600 1,383
49
785
28
FTE employee
FTE subcontractors
Staff in 2012 (full time equivalent in MD sector)
20www.Team-NB.org
Staff (full time equivalent in MD sector) : 2010 - 2012
Total Average Total AverageFTE employee FTE subcontractors
-
200
400
600
800
1,000
1,200
1,400
1,600
2010
2012
21www.Team-NB.org
>1000 200-1000 <200 -
200
400
600
800
1,000
1,200
TotalAverageMinMax
Full Time employee in 2012 (by NBs size)
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