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Presentation 2019

T he E uropean A ssociation M edical devices N otified B odies. Presentation 2019. Context of TEAM-NB. DG GROW. M R A Switzerland Canada Australia New Zealand USA Japan , …. CEN CENELEC. EMA. NB-MED. MDEG. NBRG. NBOG. COEN. Experts Groups EUDAMED, IVD , CIE

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Presentation 2019

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  1. The European Association Medical devices Notified Bodies Presentation 2019

  2. Context of TEAM-NB DG GROW • M • R • A • Switzerland • Canada • Australia • New Zealand • USA • Japan, … CEN CENELEC EMA NB-MED MDEG NBRG NBOG COEN Experts Groups EUDAMED, IVD, CIE Vigilance AMDR, EAAR, COCIR, 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 2019 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 2019 Presentation

  4. TEAM-NB 2019 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 2019 Presentation

  6. Interpretation of the new regulations • Team-NB establishedworking groups alreadyfrom 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 2019 Presentation

  7. Team-NB: MDR Designationprocess • Data collected in December 2018 with responses of 22 out of 24 members (knowing that 57 Notified Bodies currently designated for MDD and AIMD) 7 2019 Presentation

  8. Team-NB: IVDR Designationprocess • Data collected in January 2019 with responses of 20 out of 24 members (knowing that 22 Notified Bodies currently designated for IVDD with 10 members) 1 more member intend to apply for IVDR 8 2019 Presentation

  9. 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 9 2019 Presentation

  10. 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 10 2019 Presentation

  11. Transition period • MDR: From May 26th 2020 to May 26th 2024 11 2019 Presentation

  12. Transition period • IVDR: From May 26th2022 to May 26th 2024 12 2019 Presentation

  13. 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 • ContractbetweenManufacturers and NBs • update to besigned to allow surveillance audits 13 2019 Presentation

  14. 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 14 2019 Presentation

  15. 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 15 2019 Presentation

  16. 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 16 2019 Presentation

  17. Members

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