The European Association of Medical Devices – Notified Bodies
Budget
€200 — €0
EP Access
0
accredited persons
Staff
7
3 FTE
EU Grants
€3,667
Mission & Goals
The Association, is a non-profit association, with the objective to represent the European Notified Bodies for Medical Devices in their dealings with all the stakeholders of the sector; namely the European Commission, European Parlementarians, Competent Authorities of Members States, associations of the medical devices industry, Patients associations, and all sector stakeholders as well as the media. A code of Conduct (version 5) is requested to be followed by all members. The Association may, develop the exchange of scientific information on the state of the art concerning the consequences of medical devices on public health, particularly in the context of the evaluation of technical and design dossiers, products that are likely to pose significant risks to public health and that require prior evaluation of the technical and design dossier by a Notified Body before they can be placed on the market.
EU Legislative Interests
Medical devices regulations, and others related legislations through participation to meetings organised by DG Santé - medical devices unit, MDCG, EMA, and HTA (Health Technology Network) working groups on the elaboration of guidelines and the European database, EUDAMED. The legislations published by DG Connect in relation with AI Act.
Communication Activities
Press releases and position papers in relation with medical device sector. Regulatory discussions event Trainings
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
Team-NB is observer in MDCG working groups, HTA network.
Organisation Members
https://www.team-nb.org/members/
Connected Legislation
Commissioner Meetings
No recorded meetings with EU commissioners.