Notified Body Coordination Group - Medical Devices
Budget
€1
EP Access
0
accredited persons
Staff
5
1.45 FTE
EU Grants
€1
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
Commissioner Meetings
No recorded meetings with EU commissioners.