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

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:

Indic Phone: 31

Phone Number: 203460780

EU Office

Address: Say BuildingJohn M Keynesplein 9

City: Amsterdam

Country: NETHERLANDS

Phone:

Indic Phone: 31

Phone Number: 203460780

Financial Data

Closed Year:

Start Date:

End Date:

Funding Sources:

Other

Other Source Info: No funding Volunteers from Notified Bodies only Administrative Secretariat provided by DG Sante Bi-annual meetings supported by DG Sante

Contributions:

Total Budget: 0

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