11 The European Association Medical devices Notified Bodies

11

The European Association Medical devices

Notified Bodies

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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

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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

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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

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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

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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

• 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