For 2017 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 for the completion of the new Medical Device and In-Vitro Diagnostic Regulations. In this aim, our association has been very much involved in the debates which took place in the Parliament in the last years. In this context, the Team NB members agree to be submitted to a strong and harmonized assessment and surveillance system by the members’ states and the Commission.
- 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. Moreover, in the framework of “Team-NB leads you to New Regulations”
- Team-NB set up, in spring 2016, working groups to work on the new regulations in order to help the members to identify and interpret the impact of the new requirements on the notified bodies. The aim is that the working group will come with guidelines to support the members in submitting their application in the quickest time and be ready to pass their designation audit against the new regulations.
- As always, Team-NB is aiming to help the notified bodies members to provide to the sector the best possible services to ensure a harmonious standard among the members. The key point remaining the safety of patients and the trust in the European healthcare system.
Team-NB will take a proactive role during 2017, in education around the process of CE marking for Medical Devices and In-Vitro Diagnostics, including the critical role of Notified Bodies in the approval process.
Our aims are :
- To improve communications with the EC Commission, Industry, Competent Authorities and User Groups by acting as a focal point and the single voice of Notified Bodies
- To promote high technical and ethical standards in the functioning of Notified Bodies
- To increase competences in decision making processes
- To protect the legal and commercial interests of Notified Bodies in their vital role in the functioning of the three medical device directives.
TEAM-NB, The European Association Medical devices of Notified Bodies, is being formed on 2001. Today the association have 23 members. This association promotes high standards and protect the interests of Notified Bodies.
In the former years, the association has reached the following:
– web site www.team-nb.org with a public and private part :
Public part contain :
- FAQs (Frequently Asked Questions)
- Documents (GHTF, MEDDEV, MEDEG, Directives, Recommendations, Team-NB)
– detailed and easy to use minutes
– participation to NB-Med meeting
– establishment of contacts with Industry representatives- accreditation by the European Commission
– allowed to participate to MDEG meetings
– establishment of a mechanism for dialog with NBOG
– Collection of information on language requirement for label, instruction for use (IFU) and screen information & Provision of IFU by different media and different means of supply
– lobbying on proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (meeting of European Parliamentarian)
– Contacts with the German alliance of NBs
– power Point presentation of the sector
– GMDN access at a reduce fee for Members
In 2017, the fees for organisations notified under one directive: 8000 € or under two or three directives: 11000 €.
If you are interested in, don’t hesitate to contact us and we’ll send you the member form to join us. You will be entitled to join any time during 2016, but at the same fee.