For 2018 our aims are:

Team-NB is actively pursuing transparency for notified bodies in Europe.

 

forecasting

  • Encouraging the continuous improvement and development of products, allowing patients increased access to safe yet innovative devices.
  • Active involvement and support for the completion of the new Medical Device and In-Vitro Diagnostic Regulations.
  • Support to notified bodies, through our detailed and state of the art guidance documents, to ensure a harmonious standard is achieved by our members throughout Europe.
  • The promotion of innovation, but innovation that is backed by solid safety and effectiveness data. The certification of manufacturers’ products is essential to continue the confidence in Medical Devices and In-Vitro Diagnostic products.
  • Develop effective communications to ensure our members receive the latest information on all regulatory developments, including guidance, regulations and standards.

 

 

Hospital staff discussing patient charts

Advantages of being a Team-NB member:

  • Part of a recognized association
  • One voice to comments new guidance’s and to influence the regulation process
  • Attendance to the meetings organised by the Commission
  • Attendance to a lot of meetings organised by the Commission and other stakeholders
  • Availability of reports of numerous Commission and working groups meetings
  • Web site private part
  • Taiwan request that the notified bodies to have signed the Code of Conduct to participate in the TCPII mutual agreement with Europe scheme. Team-NB members only are welcome in this scheme. Thank to our contact with the Commission, members are aware of modifications earlier than other notified bodies.
  • Have GMDN submission included

 

Team-NB Presentation

TEAM -NB, The European Association Medical devices of Notified Bodies, is being formed on 2001.
Today the association has 24 members. Those 24 members represent 12 different countries.
This association promotes high standards and protects the interests of Notified Bodies.

 

In the former years, the association reached the following:

  • web site  www.team-nb.org with a public and private part :
    • public part contain among others:
      • Members list
      • Contacts
      • Documents (GHTF, MEDDEV, MEDEG, Directives, Recommendations)
    • private part
      • reports and detailed and easy to use minutes
  • accreditation by the European Commission (MDEG meetings) and set up of a dialog platform (bilateral meetings)
  • establishment of contacts with Industry representatives
  • establishment of mechanism for dialog with NBOG
  • participation to meetings with Commission, European Parliamentarian and Competent authorities
  • part of the process to establish new regulations and guidance’s
  • contribution to the setting up of the new EUDAMED data base
  • Contacts with the German alliance of NBs
  • Power Point presentation of the sector
  • GMDN access at a reduce fee for Members

From now on, for new members, there will be 2 fees :

  • Entrance fee of 10.000€ to allow to get interpretation working group phase 2 output
  • Annual 2018 membership fees for organizations notified
    • under one directive: 7.200 € or
    • under two or three directives: 9.900 €.