For 2024 our aims are:

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

• Encouraging the continuous improvement and development of products, allowing patients increased access to safe yet innovative devices.
• Active involvement and support on the implementation of the new Medical Device Regulation and the In-Vitor-Diagnostic Regulation, e.g. by supporting the creation and pragmatic update of guidances
• 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.

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.

Team-NB Presentation

TEAM -NB, The European Association Medical devices of Notified Bodies, is being formed on 2001.
Today the association has 44 members. Those 44 members represent 20 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, IMDRF, EU Recommendations MDCG, Implementing acts, Directives, Recommendations)
  • private part
    • reports and detailed and easy to use minutes
• accreditation by the European Commission ( MDCG meetings) and set up of a dialog platform (bilateral meetings)
• accreditation by the EMA and establishment of dialogues
• establishment of contacts with Industry representatives
• establishment of mechanism for dialog with NBO
• participation to meetings with Commission, European Parliamentarian, CAMD and National 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
• On-going sector survey allowing trends analyses
• Designing of Position Papers with the aim to harmonise the best practices among Notified Bodies

As decided by the General Assembly, the 2024 fees will be as in the below table :

To be able to identify the 2024 membership fee, you need to know the numbers of issued QMS certificates following both Directives and Regulations.
In details, the QMS certificates are the ones issued against

• • AIMDD – Annex 2 & 5
  • MDD Annex 2 & 5 & 6
  • IVD Annex IV
  • MDR Annex IX – 1 / IX – 3 / Annex XI part A
  • IVDR Annex IX – 1 / IX – 2 / Annex X part A

Membership fees for 2024