Notified Body Coordination Group - Medical Devices
Recent meetings
| Date | Commissioner / Cabinet | Topic | File |
|---|---|---|---|
| 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
https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview This group allows notified bodies to share experiences and exchange points of view on the application of conformity assessment procedures. Develops technical recommendations and builds consensus on issues related to conformity assessment. Advises the Commission, at its request, on medical device legislation. Prepares reports on ethical aspects of the activities of notified bodies. It ensures consistency with the standardization work carried out at European level.
EU Legislative Interests
EU 2017/745 EU 2017/746 All applicable implementing and delegated acts associated with MDR and IVDR
Communication Activities
MDCG workgroups: Notified bodies oversight (NBO) - only if invited Standards Clinical investigation and evaluation (CIE) Post-market surveillance and vigilance (PMSV) Market Surveillance (MS) - only if invited Borderline and classification (B&C) New technologies EUDAMED Unique device identification (UDI) International matters In vitro diagnostic medical devices (IVD) Nomenclature “Annex XVI” products
Interests Represented
Does not represent commercial interests
Member Of
TeamNB - Association of Notified Bodies - https://www.team-nb.org/
Connected Legislation
Public exposure limits to electromagnetic fields (0Hz-300Hz)
Pandemic influenza preparedness and response planning
Mental health
Prevention of injury and promotion of safety
Community health action programme (2007-2013)
Mental health
Health data and indicators, to provide information back-up (cancer, AIDS, etc.)
Antimicrobials reserved for human infections
Mental Health
Injury prevention (action in the field of public health)
EU Health Emergency Preparedness and Response Authority
Health concerns associated with electromagnetic fields
Mental health
Summer-time arrangements
Extension of EU public health action programmes
Public health community action programme (2001-2006)
Resolution on Taiwan (56th World Health Assembly)
European Health Insurance Card
Mental Health
Taiwan's observer status at the World Health Assembly (2002)
Mental health for the European Union