The European Association Medical devices Notified Bodies Medical
The European Association Medical devices Notified Bodies Medical Device Survey 2015 Data from 22 NBs Team-NB-MD-Survey-2015 1
Medical Device Survey 2015 Ø Valid certificates issued end of 2015 25, 000 21, 037 20, 000 15, 000 Numbers of certificate by 22 NBs > 1 000: 8 NBs 350 - 1 000: 6 NBs < 350: 8 NBs 10, 000 5, 000 956 Total Team-NB-MD-Survey-2015 Average 2
Medical Device Survey 2015 Ø Valid certificates issued 2010 – 12 – 13 – 14 - 15 25000 21530 20000 15000 22487[VALE 21460 UR] 13889 10000 5000 817 769 766 899 915 0 Total Team-NB-MD-Survey-2015 2010 (19 NBs) 2012 (28 NBs) 2013 (28 NBs) 2014 (25 NBs) 2015 (22 NBs) Average 3
Medical Device Survey 2015 Ø Distribution between different directives IVD 6% AIMDD 2% MDD 91% Team-NB-MD-Survey-2015 4
Medical Device Survey 2015 Ø Distribution between different conformity assessment modules under AIMDD Annex 5 3% Annex 3 12% Annex 2 85% Team-NB-MD-Survey-2015 5
Medical Device Survey 2015 Ø Distribution between different conformity assessment modules under MDD Annex 2 including EC design examination 21% Annex 3 1% Annex 6 1% Annex 4 2% Team-NB-MD-Survey-2015 EC design examination including combination product 1% Annex 2 50% Annex 5 24% 6
Medical Device Survey 2015 Ø Distribution between different conformity assessment modules under IVDD Annex 7 3. 76% Annex 3 24% Annex 4 72% Team-NB-MD-Survey-2015 7
Medical Device Survey 2015 Ø New certificates issued in 2015 5, 000 4, 500 4, 000 3, 500 3, 000 2, 500 2, 000 1, 500 1, 000 500 - 4, 480 204 Total Team-NB-MD-Survey-2015 Average 8
Medical Device Survey 2015 Ø New certificates issued 2010 – 12 – 13 – 14 – 15 8000 7000 6993 6000 5000 4000 3000 5061 4535 4480 2012 2013 2014 3120 2015 2000 1000 411 0 Total Team-NB-MD-Survey-2015 2010 111 181 195 Average 9
Medical Device Survey 2015 Ø Distribution between different directives in 2015 IVD 9% AIMDD 2% MDD 89% Team-NB-MD-Survey-2015 10
Medical Device Survey 2015 Ø Distribution between different conformity assessment modules under AIMDD in 2015 Annex 5 4% Annex 3 16% Annex 2 80% Team-NB-MD-Survey-2015 11
Medical Device Survey 2015 Ø Distribution between different conformity assessment modules under MDD in 2015 EC design examination with drug consultation for initial EC design 1% certification examination 1% 20% Annex 4 1% Annex 6 1% Team-NB-MD-Survey-2015 Annex 2 50% Annex 5 26% EC design examination with drug consultation: answers from 2 NBs. 12
Medical Device Survey 2015 Ø Distribution between different conformity assessment modules under IVDD in 2015 Annex 7 4% Annex 3 24% Annex 4 72% Team-NB-MD-Survey-2015 13
Medical Device Survey 2015 Ø Valid certificates against ISO 13485 25, 000 20, 157 15, 000 10, 000 5, 000 916 Total Team-NB-MD-Survey-2015 Average 14
Medical Device Survey 2015 Valid certificates against ISO 13485: 2010 – 12 – 13 – 14 – 15 Ø 24000 17113 18734 16946 20000 16000 12000 2010 (19 NBs) 2012 (28 NBs) 2013 (28 NBs) 11695 2014 (25 NBs) 2015 (22 NBs) 8000 4000 688 669 605 685 876 0 Total Team-NB-MD-Survey-20157 Average 15
Medical Device Survey 2015 Ø Number of certificates withdrawn in 2015 1, 400 1, 294 1, 200 1, 000 800 600 400 200 59 Total Team-NB-MD-Survey-2015 Reasons for withdrawing: - Transfer to another NB - Shortage of surveillance audit - stop of manufacturing / cessation of production - financial issues - no renewal / cancellation - not closing the nonconformities / negative assessment result - merges and acquisitions Average 16
Medical Device Survey 2015 Number of certificates withdrawn in 2010 – 12 – 13 – 14 – 15 Ø 1400 1200 1000 1294 1058 915 881 800 2012 600 2013 2014 400 2015 244 200 14 33 31 42 56 0 Total Team-NB-MD-Survey-2015 Average 17
Medical Device Survey 2015 Ø Certification holders EU 31% Outside EU 69% Total certification holders estimated to 28831 / 22 NBs Team-NB-MD-Survey-2015 18
Medical Device Survey 2015 Ø Staff in 2015 (full time equivalent in MD sector) 1, 800 1, 600 1, 400 1, 200 1, 000 800 600 400 200 - 1, 692 FTE Employee 606 77 Total Team-NB-MD-Survey-2015 FTE External Contractors 28 Average 33 22 Median 19
Medical Device Survey 2015 Staff (Average Full Time Equivalent in MD sector): 2010 – 12 – 13 – 14 – 15 Ø 90 77 80 65 70 60 50 2012 2013 2014 2015 45 49 46 40 28 30 18 20 26 25 28 10 0 Team-NB-MD-Survey-2015 FTE employee FTE external contractors 20
Medical Device Survey 2015 Ø Total personnel capacity in 2015 (by NBs size) 2, 000 1, 800 1, 600 1, 400 1, 200 1, 000 800 600 400 200 - 1, 717 Total Average Min Max 562 215 327 59 >1000 Team-NB-MD-Survey-2015 55 25 103 350 -1000 254 32 13 67 <350 21
- Slides: 21