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T he E uropean A ssociation M edical devices N otified B odies

T he E uropean A ssociation M edical devices N otified B odies . 1. TEAM-NB. Aims : Communication with European Commission Competent Authorities Industry Promote technical and ethical standards Participate in improving the legal framework Contribute to harmonization

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T he E uropean A ssociation M edical devices N otified B odies

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  1. The European Association Medical devices Notified Bodies 1

  2. TEAM-NB Aims: • Communication with • European Commission • CompetentAuthorities • Industry • Promotetechnical and ethical standards • Participate in improving the legal framework • Contribute to harmonization • RepresentNotified Bodies Team-NB-Presentation on Code of Conduct V3-ppt

  3. Context of TEAM-NB Commission • M • R • A • Switzerland • Canada • Australia • New Zealand • USA • Japan, … CEN CENELEC EMEA NB-MED MDEG NBRG NBOG MSOG Experts Groups EUDAMED, IVD, Vigilance VI, EUROM Contact, Assoc = EUCOMED, FIDES, EDMA, EUROM UEAPME, Eur Assoc of Auth Repr CPME Team-NB logo I M D R F Health Professionals Notified Bodies Manufacturers Authorised Reprentatives Notification National Accreditation Bodies 27 Competent Authorities TEAM-NB representatives Team-NB-Presentation on Code of Conduct V3-ppt

  4. Code of Conduct V3 • Mandatory to sign for TEAM-NB members • Available on website • Changes and additions: • Extension to IVD • Unannounced visits • Product Verification • Supervisory Structure • Peer assessment Team-NB-Presentation on Code of Conduct V3-ppt

  5. Detailed content CoC V3 • Implementation, enforcement and monitoring of the Code of Conduct • Qualification and Assignment of Notified Body Assessment Personnel • Minimum time for Notified Body assessments • Unannounced visits • Sampling of class IIa and IIb technical files • Design Dossier Reviews • Rules for subcontracting • Rules for Certification Decisions Team-NB-Presentation on Code of Conduct V3-ppt

  6. Quality of Notified Body work • Code of Conduct addresses where NBs diverge • Detailed requirements with less room to interpret • Result must be more consistent • Requires consistency in oversight => cross-inspections Integrity Independence Competence Time spent Interpretation Quality Team-NB-Presentation on Code of Conduct V3-ppt

  7. Team-NB main commitments • TEAM-NB members are committed to ensure the safety of Medical Devices on the EU market • TEAM-NB members abide by regulatory and ethical aspects by law as well as on voluntary basis • TEAM-NB members agree to be submitted to a strong and harmonized assessment and surveillance system by member states and commission • TEAM-NB members are fully aware of their responsibility to ensure certification of medical devices complies with the Directives Team-NB-Presentation on Code of Conduct V3-ppt

  8. Contacts Management: • Gert Bos (gert.bos@bsigroup.com) – president • Hans Heiner Junker(hans-heiner.junker@tuev-sued.de) – vice president • Guy Buijzen (guy.buijzen@dekra.com) – assistant vice-president • AudLøkenEiklid (Aud.Loken.Eiklid@presafe.com) - treasurer • CorinneDelorme(corinne.delorme@lne.fr) – secretary • Françoise Schlemmer (schlemmer@quasys.com) -Director and Secretariat www.team-nb.org Team-NB-Presentation on Code of Conduct V3-ppt

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