Notified Body Coordination Group - Medical Devices
Acronym: NBCG-Med
General Information
Identification Code: 482645249107-28
Entity Form: Legal status from MDR Article 49 & IVDR Article 45
Registration Category: Other organisations, public or mixed entities
Registration Date: 2/16/2023
Last Update: 2/26/2024
EP Accredited Number: 0
Mission & Interests
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.
Interests Represented: Does not represent commercial interests
Interests:
- Public health
Levels of Interest:
- national
- global
- european
- sub-national
Activities
Main EU Legislative Proposals: 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
EU Supported Forums and Platforms: 08 - EUDAMED#X03565/13#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100886 #OBSERVER #C#Other02 - Standards#X03565/4#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100599 #OBSERVER #C#Other09 - Unique Device Identification (UDI)#X03565/10#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100606 #OBSERVER #C#OtherMedical Device Coordination Group#X03565#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565 #OBSERVER #C#Other11 - In vitro Diagnostic Medical Devices (IVD)#X03565/12#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100608 #OBSERVER #C#Other12 - Nomenclature#X03565/1#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100117 #OBSERVER #C#Other13 - Annex XVI #X03565/2#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100252 #OBSERVER #C#Other04 - Post-Market Surveillance and Vigilance (PMSV)#X03565/6#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100601 #OBSERVER #C#Other06 - Borderline and Classification (B&C)#X03565/8#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100603 #OBSERVER #C#Other07 - New Technologies#X03565/9#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100604 #OBSERVER #C#Other03 - Clinical Investigation and Evaluation (CIE)#X03565/5#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100600 #OBSERVER #C#Other10 - International Matters#X03565/11#https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=100607 #OBSERVER #C#Other
Inter-institutional or Unofficial Groupings: Unofficial groupings
Head Office
Address: Say BuildingJohn M Keynesplein 9
City: Amsterdam
Country: NETHERLANDS
Phone: [object Object]
EU Office
Address: Say BuildingJohn M Keynesplein 9
City: Amsterdam
Country: NETHERLANDS
Phone: [object Object]
Financial Data
New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]
Membership Information
Members10 Percent: 2
Members25 Percent: 1
Members50 Percent: 2
Members75 Percent: 0
Members: 5
Members F T E: 1.4500000476837158
Info Members: Executive Committee - Two Chair Persons, NB Technical WG Chair - MD, NB Technical WG Chair - IVD, Secretary
Structure
Structure Type: Structure
Organisation Members: TeamNB - Association of Notified Bodies - https://www.team-nb.org/