Analysis of Medical Device Certificates Issued in Europe

This data analysis presents information on the distribution of valid certificates, new certificates issued, and distribution between different directives and conformity assessment modules for medical devices in Europe. The data covers the years 2010, 2012, and 2013, providing insights into the number of certificates issued by Notified Bodies and the conformity assessment modules under various directives. The analysis reveals the trends in certificate issuance and conformity assessment practices within the European medical device industry.

• Medical devices
• Certificates issuance
• European Association
• Notified Bodies
• Data analysis

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1. Medical Device Survey 2013 data from 28 NBs The European Association Medical devices - Notified Bodies - www.Team-NB.org

2. Valid certificates issued end of 2013 25,000 Numbers of certificate by 28 NBs > 1 000: 200 - 1 000: < 200: 21,460 7 NBs 14 NBs 7 NBs 20,000 15,000 10,000 5,000 766 - Total Average www.Team-NB.org 2

3. Valid certificates issued 2010-2012-2013 25000 21530 20000 21460 15000 13889 2010 (19 NBs) 2012 (28 NBs) 2013 (28 NBs) 10000 5000 817 769 766 0 Total Average www.Team-NB.org 3

4. Distribution between different directives IVD 6% AIMDD 4% MDD 90% www.Team-NB.org 4

5. Distribution between different conformity assessment modules under AIMDD Annex 5 3% Annex 4 5% Annex 3 12% Annex 2 80% www.Team-NB.org 5

6. Distribution between different conformity assessment modules under MDD Annex 2 including EC design examination 20% EC design examination including combination product 2% Annex 2 47% Annex 3 1% Annex 4 4% Annex 5 24% Annex 6 1% * ECDE: EC Design Examination - EC design examination with drug consultation: answers from 10 NBs. www.Team-NB.org 6

7. Distribution between different conformity assessment modules under IVDD Annex 7 3.89% Annex 3 29% Annex 4 67% www.Team-NB.org 7

8. New certificates issued in 2013 6,000 5,061 5,000 4,000 3,000 2,000 1,000 181 - Total Average www.Team-NB.org 8

9. New certificates issued : 2010 2012 - 2013 8000 6993 7000 6000 5061 5000 2010 2012 4000 3120 2013 3000 2000 1000 411 181 111 0 Total Average www.Team-NB.org 9

10. Distribution between different directives in 2013 IVD 10% AIMDD 3% MDD 87% www.Team-NB.org 10

11. Distribution between different conformity assessment modules under AIMDD in 2013 Annex 4 8% Annex 5 Annex 3 2% 5% Annex 2 85% www.Team-NB.org 11

12. Distribution between different conformity assessment modules under MDD in 2013 EC design examination with drug consultation 1% EC design examination with drug consultation for initial certification 1% EC design examination 16% Annex 3 1% Annex 2 51% Annex 4 1% Annex 5 27% Annex 6 2% EC design examination with drug consultation: www.Team-NB.org 12

13. Distribution between different conformity assessment modules under IVDD in 2013 Annex 7 5% Annex 3 25% Annex 4 70% www.Team-NB.org 13

14. Valid certificates against ISO 13485 18,000 16,946 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 605 - www.Team-NB.org 14

15. Valid certificates against ISO 13485 : 2010 2012 - 2013 20000 18734 18000 16946 16000 14000 11695 2010 (19 NBs) 12000 2012 (28 NBs) 10000 2013 (28 NBs) 8000 6000 4000 688 2000 669 605 0 Total Average www.Team-NB.org 15

16. Number of certificates withdrawn in 2013 1,000 881 900 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 800 700 600 500 400 300 200 100 31 - www.Team-NB.org 16

17. Number of certificates withdrawn in 2010 2012 - 2013 1000 915 881 900 800 700 2010 600 2012 500 2013 400 300 244 200 100 33 31 14 0 Total Average www.Team-NB.org 17

18. Certification Holders EU 35% Worldwide (outside EU) 65% Total certification holders estimated to 21 450 / 28 NBs www.Team-NB.org 18

19. Staff in 2013 (full time equivalent in MD sector) 1,400 1,291 FTE employee 1,200 FTE subcontractors 1,000 739 800 600 400 200 46 26 - Total Average www.Team-NB.org 19

20. Staff (full time equivalent in MD sector):2010 2012 - 2013 1,600 1,383 1,400 1291 1,200 1,000 785 770 2010 2012 2013 739 800 600 400 310 200 49 28 46 45 26 18 - Total Average Total Average FTE employee FTE subcontractors www.Team-NB.org 20

21. Total personnel capacity in 2013 (by NBs size) 1,400 1,292 Total 1,200 Average 1,000 Min Max 800 604 600 481 400 185 134 200 113 51 48 43 19 16 11 - >1000 200-1000 <200 www.Team-NB.org 21

22. Medical Device Survey 2013 In case of any further clarification needed, please contact info@team-nb.org Administrative Committee President : Vice President : Assistant Vice President : Treasurer: Secretary: Gert Bos Hans-Heiner Junker Guy Buijzen Aud L ken Eiklid Corinne Delorme Director: Fran oise Schlemmer www.Team-NB.org 22

23. Medical Device Survey 2013 TEAM-NB: Members www.Team-NB.org 23