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11
The European Association Medical devices
Notified Bodies
2
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
TEAM-NB
3
Context of TEAM-NB
TEAM-NB representatives
logo
IMDRF
Commission
CEN CENELEC
EMEA
NBRG
CPME
Health Professionals
Team-NB
VI, EUROM Contact,Assoc = EUCOMED,
FIDES, EDMA, EUROMUEAPME, Eur Assoc of
Auth Repr
Notified Bodies Manufacturers
National Accreditation
Bodies
27 Competent Authorities
MRA
- Switzerland- Canada- Australia- New
Zealand- USA- Japan, …
Authorised Reprentatives
NB-MED
Notification
MDEG
NBOG MSOGExperts Groups
EUDAMED,IVD,
Vigilance
Team-NB-Presentation on Code of Conduct V3-ppt
• Mandatory to sign for TEAM-NB members
• Available on website• Changes and additions:
– Extension to IVD– Unannounced visits– Product Verification– Supervisory Structure– Peer assessment
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Code of Conduct V3
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
5Team-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
IndependenceIntegrity Competence
Time spent
Quality
Interpretation
6Team-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
7Team-NB-Presentation on Code of Conduct V3-ppt
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Contacts
Management:
• Gert Bos ([email protected]) – president
• Hans Heiner Junker ([email protected]) – vice president
• Guy Buijzen ([email protected]) – assistant vice-president
• Aud Løken Eiklid ([email protected]) - treasurer
• Corinne Delorme ([email protected]) – secretary
• Françoise Schlemmer ([email protected]) -Director and Secretariat
www.team-nb.org
Team-NB-Presentation on Code of Conduct V3-ppt