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


• 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


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


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 ([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


11 The European Association Medical devices Notified Bodies.

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Transcript of 11 The European Association Medical devices Notified Bodies.