Team-NB stated for The European Association for Medical devices of Notified Bodies.

We are a not for profit association.

Our members are Notified Bodies (see member list) under any or all of the three medical device new approach directives: 90/385/EEC; 93/42/EEC; 98/79/EC.

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 protect the legal and commercial interests of Notified Bodies in their vital role in the functioning of the three medical device directives

Team-NB Presentation

TEAM-NB, The European Association Medical devices of Notified Bodies, is being formed on 2001. Today the association have 32 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 :

• Home
• Members
• Contacts
• Links
• FAQs (Frequently Asked Questions)
• News
• Search
• Documents (GHTF, MEDDEV, MEDEG, Directives, Recommandations, Team-NB)
• Sitemap

- 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

For 2010 our aims are:

*  set up a code of conduct 
*  Inform the members of the trends concerning the recast

In 2010, you will still benefit of reduced fees for organisations notified under one directive: 1.500 € or under two or three directives: 2.250 €.

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 2010, but at the same fee.