The European Association Medical devices

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Presentation transcript:

The European Association Medical devices Notified Bodies 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 Represent Notified Bodies Team-NB-Presentation on Code of Conduct V3-ppt

Context of TEAM-NB Commission TEAM-NB representatives CEN CENELEC EMEA 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

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

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

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

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

Contacts www.team-nb.org 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 Aud Løken Eiklid (Aud.Loken.Eiklid@presafe.com) - treasurer Corinne Delorme (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