The European Association of Medical Devices – Notified Bodies
Recent meetings
| Date | Commissioner / Cabinet | Topic | File |
|---|---|---|---|
| 18 Nov 2025 | Olivér Várhelyi Commissioner | Medical device review | — |
| 18 Nov 2025 | Olivér Várhelyi Commissioner | Medical device review | SRC |
| 31 Jul 2025 | Lorena Boix Alonso Deputy Director-General | Exchange of views on the state of play and next steps for the medical devices sector. | — |
| 31 Jul 2025 | Flora Giorgio Head of Unit | Exchange of views on the state of play and next steps for the medical devices sector. | — |
| 31 Jul 2025 | Rainer Becker Director | Exchange of views on the state of play and next steps for the medical devices sector. | SRC |
| 31 Jul 2025 | Rainer Becker Director | Exchange of views on the state of play and next steps for the medical devices sector. | — |
| 31 Jul 2025 | Flora Giorgio Head of Unit | Exchange of views on the state of play and next steps for the medical devices sector. | SRC |
| 31 Jul 2025 | Lorena Boix Alonso Deputy Director-General | Exchange of views on the state of play and next steps for the medical devices sector. | SRC |
| 17 Feb 2025 | Flora Giorgio Head of Unit | Opportunities for the improvement of harmonisation and predictability of conformity assessment procedures under MDR / IVDR. Involvement of Commission representatives during the NBCG-Med plenary meeting planned in April 2025. | — |
| 17 Feb 2025 | Flora Giorgio Head of Unit | Opportunities for the improvement of harmonisation and predictability of conformity assessment procedures under MDR / IVDR. Involvement of Commission representatives during the NBCG-Med plenary meeting planned in April 2025. | SRC |
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
Mental Health
Pandemic influenza preparedness and response planning
Resolution on Taiwan (56th World Health Assembly)
Public Health Community Action Programme (2001-2006)
Community health action programme (2007-2013)
Public exposure limits to electromagnetic fields (0Hz-300Hz)
Health concerns associated with electromagnetic fields
Mental health for the European Union
Antimicrobials reserved for human infections
Health data and indicators, to provide information back-up (cancer, AIDS, etc.)
Summer-time arrangements
Mental health
EU Health Emergency Preparedness and Response Authority
Mental health
Extension of EU public health action programmes
Mental health
European Health Insurance Card
Mental Health
Taiwan's observer status at the World Health Assembly (2002)
Injury prevention (action in the field of public health)
Prevention of injury and promotion of safety
Medical devices
Medical devices