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Presentation 2018

T he E uropean A ssociation M edical devices N otified B odies. Presentation 2018. Context of TEAM-NB. Commission. M R A Switzerland Canada Australia New Zealand USA Japan , …. CEN CENELEC. EMA. NB-MED. MDEG. NBRG. NBOG. COEN. Experts Groups EUDAMED, IVD, Vigilance.

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Presentation 2018

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  1. The European Association Medical devices Notified Bodies Presentation 2018

  2. Context of TEAM-NB Commission • M • R • A • Switzerland • Canada • Australia • New Zealand • USA • Japan, … CEN CENELEC EMA NB-MED MDEG NBRG NBOG COEN Experts Groups EUDAMED, IVD, Vigilance AMDR, EAAR, EUROMContact, MedTech Europe, FIDES, EDMA, EUROM UEAPME, CMC CPME logo I M D R F Health Professionals Notified Bodies Manufacturers AuthorisedRepresentatives Notification Accreditation 28 CompetentAuthorities National Accreditation Bodies TEAM-NB representatives 2 2018 Presentation

  3. TEAM-NB • Aims: • Communication with • European Commission • CompetentAuthorities • Industry • Promotetechnical and ethical standards • Participate in improving the legal framework • Contribute to harmonization • RepresentNotified Bodies 3 2018 Presentation

  4. TEAM-NB 2018 Presentation

  5. Code of Conduct V 3.4 • Mandatory to sign for TEAM-NB members • Version 3.4 approved • Available on website www.team-nb.org 2018 Presentation

  6. Interpretation of the new regulations • Team-NB establishedworking groups from April 2016 • Aim: formulate an analyse of the new regulations and propose to the members • Procedures to be put in place • To-dolists • … to bedoneto submit application for designation and/or wait for implementing acts • Help members to bedesignated • Allow harmonisation Classification & Conformity Assessment NB requirements Clinical Vigilance 6 2018 Presentation

  7. Team-NB: designation process • 80% of applications before February 2018 • 50% for bigger scope of application • 50% for same scope of application • 55% of the members are candidates for IVDR • 73% applied before February 2018 • 27% to apply in 2018 7 2018 Presentation

  8. Designationof notifiedbodies • Notified body designatedaccording to MDR / IVDR before certification of manufacturers • Steps • List of codes published in an implementing act - November 2017 • Introduction of an application for designation by NBs • On November 26th, 2017 at the earliest • 80% of the members did it 2017 8 2018 Presentation

  9. Designationof notifiedbodies • Steps (… to befollowed) • Joint audit assessment • April 2018: 3 assessments performed • ... • Conformity assessment bodies designated on NANDO • Transparency of the designation process (on-going survey) • All codes to be covered 9 2018 Presentation

  10. Transition period EIF: Entry Into Force EIA: Entry Into Application • MDR: From May 26th 2020 to May 2024 • IVDR: From May 26th 2022 to May 2024 • ContractbetweenManufacturers and NBs • update to besigned to allow surveillance audits 10 2018 Presentation

  11. Transition period • CE mark after "Entry into Application" • Compliance with MDD or AIMD • No significant change in design and intendedpurpose • Application of the requirements of the Regulationsrelated to • Post-market surveillance, Market surveillance, Vigilance, Registration of economicoperators and devices, • NB remains in charge of surveillance 11 2018 Presentation

  12. Commission tools Under the MDCG supervision Common specifications New instrument to be adopted by implementing acts which manufacturers will need to apply Delegated and implementing acts instrument to precise regulation articles Regulation tools 12 2018 Presentation

  13. European databank on MD (EUDAMED) • Use of a medical device nomenclature mandatory • Data to be uploaded to collate and process information regarding MD • SRN – single registration number • UDI – unique device identifier -> traceability • aspects of conformity assessment • notified bodies • certificates • clinical investigations • vigilance and market surveillance 13 2018 Presentation

  14. Contacts Management: • Guy Buijzen (guy.buijzen@dekra.com) – president • Kevin Butcher (kevin.butcher@sgs.com) – vice president • Corinne Delorme (Corinne.Delorme@lne-gmed.com) – secretary • Hans Heiner Junker(hans-heiner.junker@tuev-sued.de) – vice president • Alexey Shiryaev(Alexey.Shiryaev@presafe.com) - treasurer • Françoise Schlemmer (schlemmer@quasys.com) -Director and Secretariat www.team-nb.org 14 2018 Presentation

  15. Members 15 2018 Presentation

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