1. The European Association Medical devices
Notified Bodies 1

2. 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

3. 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

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 www.team-nb.org Management:
Gert Bos – president
Hans Heiner Junker – vice president
Guy Buijzen – assistant vice-president
Aud Løken Eiklid - treasurer
Corinne Delorme – secretary
Françoise Schlemmer -Director and Secretariat
Team-NB-Presentation on Code of Conduct V3-ppt