For 2019 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, The European Association Medical devices of Notified Bodies, is being formed on 2001.
Today the association has 26 members. Those 26 members represent 14 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
- 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
- On-going sector survey allowing trends analyses
From now on, for new members, there will be 2 fees :
- Annual 2019 membership fees for organizations notified
- under one directive: 7.200 € or
- under two or three directives: 9.900 €.