European Medical Devices Survey 2018 Insights
The European Association of Medical Devices Notified Bodies conducted a comprehensive survey in 2018, showcasing data on valid certificates issued, distribution between different directives, conformity assessment modules, and new certificates issued. The survey provides valuable information on the certification landscape, including the number of certificates issued, validity, and distribution across different criteria and modules.
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The European Association Medical devices Notified Bodies Medical Device Survey 2018 Data from all 23 members (end 2018) Team-NB-MD-Survey-2018 1
Medical Device Survey 2018 Valid certificates issued end of 2018 20,000 18,449 Numbers of certificate by 23 NBs > 1 000: 5 NBs 350 - 1 000: 6 NBs < 350: 12 NBs 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 802 296 - Total Average Median Team-NB-MD-Survey-2018 2
Medical Device Survey 2018 Valid CE certificates issued from 2010 to 2018 25,000 22,487 21,037 21,530 2010 (17 NBs) 2012 (28 NBs) 2013 (28 NBs) 2014 (25 NBs) 2015 (22 NBs) 2016 (21 NBs) 2017 (24 NBs) 2018 (23 NBs) 21,460 19,775 19,763 20,000 18,449 13,889 15,000 10,000 5,000 956 941 899 824 817 802 769 766 - Total Average Team-NB-MD-Survey-2018 3
Medical Device Survey 2018 Distribution between different directives AIMDD 2% IVD 7% MDD 91% Team-NB-MD-Survey-2018 4
Medical Device Survey 2018 Distribution between different conformity assessment modules under AIMDD Annex 4 0% Annex 5 3% Annex 3 5% Annex 2 93% Team-NB-MD-Survey-2018 5
Medical Device Survey 2018 Distribution between different conformity assessment modules under MDD EC design examination including combination product 1% EC design examination 22% Annex 2 48% Annex 3 1% Annex 4 2% Annex 5 24% Annex 6 1% Team-NB-MD-Survey-2018 6
Medical Device Survey 2018 Distribution between different conformity assessment modules under IVDD Annex 7 3% Annex 3 18% Annex 4 79% Team-NB-MD-Survey-2018 7
Medical Device Survey 2018 New certificates issued in 2018 6,000 4,992 5,000 4,000 3,000 2,000 1,000 217 - Total Average Team-NB-MD-Survey-2018 8
Medical Device Survey 2018 New CE certificates issued from 2010 to 2018 8,000 2010 2012 6,993 7,000 2013 2014 6,000 2015 2016 4,480 5,061 4992 3,847 4,535 5,000 2017 2018 4,098 4,000 3,120 3,000 2,000 1,000 411 217 204 195 181 181 160 111 - Total Average Team-NB-MD-Survey-2018 9
Medical Device Survey 2018 Distribution between different directives in 2018 AIMDD 2% IVD 8% MDD 90% Team-NB-MD-Survey-2018 10
Medical Device Survey 2018 Distribution between different conformity assessment modules under AIMDD in 2018 Annex 4 4% Annex 5 4% Annex 3 14% Annex 2 78% Team-NB-MD-Survey-2018 11
Medical Device Survey 2018 Distribution between different conformity assessment modules under MDD in 2018 EC design examination with drug consultation 1% Annex 3 0% EC design examination 17% EC design examination with drug consultation for initial certification 0% Annex 4 1% Annex 6 1% Annex 2 53% Annex 5 27% EC design examination with drug consultation: answers from 7 NBs Team-NB-MD-Survey-2018 12
Medical Device Survey 2018 Distribution between different conformity assessment modules under IVDD in 2018 Annex 7 3% Annex 3 18% Annex 4 79% Team-NB-MD-Survey-2018 13
Medical Device Survey 2018 Valid certificates against ISO 13485 25,000 20,545 20,000 15,000 10,000 5,000 893 - Total Average Team-NB-MD-Survey-2018 14
Medical Device Survey 2018 Valid certificates against ISO 13485: 2010 12 13 14 15 16 17 2018 2010 (19 NBs) 28,000 23,484 2012 (28 NBs) 24,000 22,523 20,157 2013 (28 NBs) 20,545 17,113 20,000 18,734 2014 (25 NBs) 16,946 2015 (22 NBs) 16,000 11,695 2016 (21 NBs) 12,000 2017 (24 NBs) 8,000 2018 (23 NBs) 4,000 1118 938 916 893 688 685 669 605 - Total Average Team-NB-MD-Survey-2018 15
Medical Device Survey 2018 Number of certificates withdrawn in 2018 1,400 1,220 Reasons for withdrawing: cessation of activity - financial issues - not closing the NCs / negative assessment result - Customer refuses audit or contact not possible - Transfer / no longer manufacturing product - merges and acquisitions - liquidations - change of NB - BREXIT - NB too expensive - Scheme restructure - Enforced cancellation 1,200 1,000 800 600 400 200 53 - Total Average Team-NB-MD-Survey-2018 16
Medical Device Survey 2018 Number of certificates withdrawn in 2010 12 13 14 15 16 17 2018 1,881 1,800 2,000 2010 2012 2013 2014 2015 2016 2017 2018 1,600 1,400 1,294 1,220 1,043 1,200 1,058 1,000 915 881 800 600 400 244 200 90 56 53 43 42 33 31 14 - Total Average Team-NB-MD-Survey-2018 17
Medical Device Survey 2018 Certification holders EU 30% Outside EU 70% Total certification holders estimated to 18 449 / 23 NBs Team-NB-MD-Survey-2018 18
Medical Device Survey 2018 Staff in 2018 (full time equivalent in MD sector) 3,000 2,605 FTE Employee 2,500 FTE External Contractors 2,000 1,500 1,000 531 500 113 41 23 21 - Total Average Median Team-NB-MD-Survey-2018 19
Medical Device Survey 2018 Staff (Average Full Time Equivalent in MD sector): 2010 12 13 14 15 16 17 2018 120 2010 2012 2013 2014 2015 2016 2017 2018 113 100 91 86 77 80 65 60 49 46 45 40 28 28 26 26 25 25 23 18 20 0 FTE employee FTE external contractors Team-NB-MD-Survey-2018 20
Medical Device Survey 2018 Total personnel capacity in 2018 (by NBs size) 2,500 Total 2,028 2,000 Average Min 1,500 Max 1,000 800 727 406 500 380 249 174 121 68 53.5 32 5 - >1000 350-1000 <350 issued certificates Team-NB-MD-Survey-2018 21
Members Team-NB-MD-Survey-2018 22
