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)

4www.Team-NB.org

AIMDD2%

MDD92%

IVD6%

Distribution between different directives

2010

MDD : 93%

IVD : 5%

AIMDD : 2%

5www.Team-NB.org

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%

6www.Team-NB.org

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%

7www.Team-NB.org

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%

8www.Team-NB.org

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%

11www.Team-NB.org

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)