Analysis of European Association Medical Devices Notified Bodies and Certificates Data
The European Association Medical Devices Notified Bodies conducted a survey in 2017, revealing data on valid certificates issued, CE certificates, distribution between different directives, and conformity assessment modules under various regulations. The survey also highlighted the number of new certificates issued in 2017 and over the years. The data provides insights into the medical device landscape within Europe.
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The European Association Medical devices Notified Bodies Medical Device Survey 2017 Data from all members - 24 NBs Team-NB-MD-Survey-2017 1
Medical Device Survey 2017 Valid certificates issued end of 2017 25,000 Numbers of certificate by 24 NBs > 1 000: 6 NBs 350 - 1 000: 4 NBs < 350: 14 NBs 19,775 20,000 15,000 10,000 5,000 824 - Total Average Team-NB-MD-Survey-2017 2
Medical Device Survey 2017 Valid CE certificates issued from 2010 to 2017 25,000 21,530 22,487 2010 (17 NBs) 2012 (28 NBs) 2013 (28 NBs) 2014 (25 NBs) 2015 (22 NBs) 2016 (21 NBs) 2017 (24 NBs) 21,460 21,037 19,775 19,763 20,000 13,889 15,000 10,000 5,000 956 941 899 824 817 769 766 - Total Average Team-NB-MD-Survey-2017 3
Medical Device Survey 2017 Distribution between different directives IVD 7% AIMDD 3% MDD 90% Team-NB-MD-Survey-2017 4
Medical Device Survey 2017 Distribution between different conformity assessment modules under AIMDD Annex 4 0% Annex 5 3% Annex 3 8% Annex 2 90% Team-NB-MD-Survey-2017 5
Medical Device Survey 2017 Distribution between different conformity assessment modules under MDD EC design examination including combination product 1% EC design examination 22% Annex 2 47% Annex 3 1% Annex 4 2% Annex 5 24% Annex 6 1% Team-NB-MD-Survey-2017 6
Medical Device Survey 2017 Distribution between different conformity assessment modules under IVDD Annex 7 2.41% Annex 3 20% Annex 4 78% Team-NB-MD-Survey-2017 7
Medical Device Survey 2017 New certificates issued in 2017 4,500 3,847 4,000 3,500 3,000 2,500 2,000 1,500 1,000 500 160 - Total Average Team-NB-MD-Survey-2017 8
Medical Device Survey 2017 New CE certificates issued from 2010 to 2017 8,000 2010 6,993 7,000 2012 6,000 2013 5,061 4,535 4,480 5,000 2014 4,098 3,847 2015 4,000 3,120 2016 3,000 2017 2,000 1,000 411 204 195 181 181 160 111 - Total Average Team-NB-MD-Survey-2017 9
Medical Device Survey 2017 Distribution between different directives in 2017 AIMDD 2% IVD 8% MDD 90% Team-NB-MD-Survey-2017 10
Medical Device Survey 2017 Distribution between different conformity assessment modules under AIMDD in 2017 Annex 3 4% Annex 5 2% Annex 4 1% Annex 2 93% Team-NB-MD-Survey-2017 11
Medical Device Survey 2017 Distribution between different conformity assessment modules under MDD in 2017 EC design examination with drug consultation 1% EC design examination with drug consultation for initial certification 0% EC design examination 19% Annex 3 1% Annex 2 47% Annex 4 0% Annex 6 1% Annex 5 31% EC design examination with drug consultation: answers from 5 NBs Team-NB-MD-Survey-2017 12
Medical Device Survey 2017 Distribution between different conformity assessment modules under IVDD in 2017 Annex 7 2% Annex 3 23% Annex 4 75% Team-NB-MD-Survey-2017 13
Medical Device Survey 2017 Valid certificates against ISO 13485 25,000 22,523 20,000 15,000 10,000 5,000 938 - Total Average Team-NB-MD-Survey-2017 14
Medical Device Survey 2017 Valid certificates against ISO 13485: 2010 12 13 14 15 16 17 28,000 2010 (19 NBs) 23,484 2012 (28 NBs) 24,000 22,523 20,157 2013 (28 NBs) 20,000 18,734 17,113 16,946 2014 (25 NBs) 16,000 2015 (22 NBs) 11,695 12,000 2016 (21 NBs) 8,000 2017 (24 NBs) 4,000 1118 938 916 688 685 669 605 - Total Average Team-NB-MD-Survey-2017 15
Medical Device Survey 2017 Number of certificates withdrawn in 2017 Reasons for withdrawing: - suspension, - closure of location, - company reorganisation, - voluntary cancellation, - requirements not met, - failure to close non - -conformities, - stop of manufacturing, - negative assessment result, - financiel issues, - audit-review not performed, - NB to expensive, - class modification, - NB change 1,200 1,043 1,000 800 600 400 200 43 - Total Average Team-NB-MD-Survey-2017 16
Medical Device Survey 2017 Number of certificates withdrawn in 2010 12 13 14 15 16 - 17 2,000 1,881 1,800 2010 2012 2013 2014 2015 2016 2017 1,600 1,400 1,294 1,200 1,058 1,043 1,000 915 881 800 600 400 244 200 90 56 43 42 33 31 14 - Total Average Team-NB-MD-Survey-2017 17
Medical Device Survey 2017 Certification holders EU 29% Outside EU 71% Total certification holders estimated to 19 775 / 24 NBs Team-NB-MD-Survey-2017 18
Medical Device Survey 2017 Staff in 2017 (full time equivalent in MD sector) 2,500 2,183 FTE Employee 2,000 1,500 FTE External Contractors 1,000 623 500 91 39 26 22 - Total Average Median Team-NB-MD-Survey-2017 19
Medical Device Survey 2017 Staff (Average Full Time Equivalent in MD sector): 2010 12 13 14 15 16 - 17 2010 2012 2013 2014 2015 2016 2017 100 91 86 90 77 80 65 70 60 49 46 45 50 40 28 28 26 26 25 25 30 18 20 10 0 FTE employee FTE external contractors Team-NB-MD-Survey-2017 20
Medical Device Survey 2017 Total personnel capacity in 2017 (by NBs size) 1,903 2,000 Total 1,800 1,600 Average 1,400 Min 1,200 1,000 Max 800 641 510 600 392 317 400 150 141 98 200 65 51.5 36 5.2 - >1000 350-1000 <350 issued certificates Team-NB-MD-Survey-2017 21
Members 22 17 Team-NB-MD-Survey-2017
