The European Association Medical devices - Notified Bodies - www.Team-NB.org

Medical Device

Survey

2013 data from 28 NBs

2 www.Team-NB.org

21,460

766

-

5,000

10,000

15,000

20,000

25,000

Total Average

Valid certificates issued end of 2013

Numbers of certificate by 28 NBs > 1 000: 7 NBs 200 - 1 000: 14 NBs < 200: 7 NBs

3 www.Team-NB.org

13889

817

21530

769

21460

766 0

5000

10000

15000

20000

25000

Total Average

Valid certificates issued 2010-2012-2013

2010 (19 NBs)

2012 (28 NBs)

2013 (28 NBs)

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Distribution between different directives

AIMDD 4%

MDD 90%

IVD 6%

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Distribution between different conformity assessment

modules under AIMDD

Annex 2 80%

Annex 3 12%

Annex 4 5%

Annex 5 3%

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Distribution between different conformity assessment

modules under MDD

Annex 2 47%

Annex 5 24% Annex 6

1%

Annex 4 4%

Annex 3 1%

Annex 2 including EC

design examination

20%

EC design examination

including combination

product 2%

* 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 3 29%

Annex 4 67%

Annex 7 3.89%

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New certificates issued in 2013

5,061

181

-

1,000

2,000

3,000

4,000

5,000

6,000

Total Average

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New certificates issued : 2010 – 2012 - 2013

6993

411

3120

111

5061

181 0

1000

2000

3000

4000

5000

6000

7000

8000

Total Average

2010

2012

2013

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Distribution between different directives in 2013

AIMDD 3%

MDD 87%

IVD 10%

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Distribution between different conformity assessment

modules under AIMDD in 2013

Annex 2 85%

Annex 3 2%

Annex 4 8%

Annex 5

5%

12 www.Team-NB.org

Distribution between different conformity assessment

modules under MDD in 2013

Annex 2 51%

Annex 5 27% Annex 6

2%

Annex 4 1%

Annex 3 1%

EC design examination

16%

EC design examination

with drug consultation

1%

EC design examination

with drug consultation

for initial certification

1%

EC design examination with drug consultation:

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Distribution between different conformity assessment

modules under IVDD in 2013

Annex 3 25%

Annex 4 70%

Annex 7 5%

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Valid certificates against ISO 13485

16,946

605

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

15 www.Team-NB.org

Valid certificates against ISO 13485 : 2010 – 2012 - 2013

11695

688

18734

669

16946

605 0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

Total Average

2010 (19 NBs)

2012 (28 NBs)

2013 (28 NBs)

16 www.Team-NB.org

Number of certificates withdrawn in 2013

881

31

-

100

200

300

400

500

600

700

800

900

1,000

Reasons for withdrawing:

- Clients cancellations

- Non compliances

- Refusal to have an audit

- Not adapted to

requirements of MDD

annex X

- Major non-conformities

- Acquisition by larger

organization

- Stop of activities

17 www.Team-NB.org

Number of certificates withdrawn in 2010 – 2012 - 2013

244

14

915

33

881

31

0

100

200

300

400

500

600

700

800

900

1000

Total  Average

2010

2012

2013

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Certification Holders

Worldwide (outside EU)

65%

EU 35%

Total certification holders estimated to 21 450 / 28 NBs

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Staff in 2013 (full time equivalent in MD sector)

1,291

46

739

26 -

200

400

600

800

1,000

1,200

1,400

Total Average

FTE employee

FTE subcontractors

20 www.Team-NB.org

Staff (full time equivalent in MD sector):2010 – 2012 - 2013

770

45

310

18

1,383

49

785

28

1291

46

739

26 -

200

400

600

800

1,000

1,200

1,400

1,600

Total Average Total Average

FTE employee FTE subcontractors

2010

2012

2013

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Total personnel capacity in 2013 (by NBs size)

1,292

604

134 185

43 19 51 16 11

481

113 48

-

200

400

600

800

1,000

1,200

1,400

>1000 200-1000 <200

Total

Average

Min

Max

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Medical Device Survey 2013

In case of any further clarification needed, please contact info@team-nb.org

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