1 / 8

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

flavio
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related