On 6 November 2001 a group of leading Notified Bodies working in the field of medical devices agreed to form a European association. Organisations entitled to become members are all European based organisations Notified under any or all of the three medical device new approach directives: 90/385/EEC; 93/42/EEC; 98/79/EC.

Initially 19 organisations have agreed to join and it is estimated that they represent about 80% of the world-wide medical device Notified Body certification activity. Several more bodies have expressed an interest in joining.

The intention is to set up a non-profit association , registered in Belgium.

This Association will be active thanks to a small structure with Representatives to attend meetings.

It is hoped that this will be legally established within several months and fully active by April 2002.

The aims of the association have yet to be fully documented but generally will be 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"

As Chris Jepson who is provisionally co-ordinating a small management team said 'Other stakeholders in medical device certification have long had their organisations ,such as EUCOMED for manufacturers, and it has been felt for some time that Notified Bodies should have a similar body. It is expected that EA NB MED will soon be seen as the authentic and representative voice of Notified Bodies in the field of medical devices.