In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG). This was in response to widespread concern that the performance of Notified
Bodies in the medical device sector, and that of the Designating Authorities responsible for them, was variable and inconsistent.
Accordingly NBOG’s terms of reference were agreed to be:
To improve the overall performance of Notified Bodies in the medical devices sector by primarily identifying and promulgating examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control.
The Group first met in November 2000 and produced a suggested work programme which was endorsed by Member States in December 2000.
NBOG membership consists of the European Commission, and nominees from the Member States Designating/Competent Authorities. Additionally, membership of the Group is open to EFTA/EEA Competent Authorities as well as Candidate and Accession countries.
On the whole, members of the Group are nominated by their Competent Authorities on the basis of their expertise in the area of Notified Body designation and control.
NBOG is chaired by a representative of a Member State’s Competent Authority and hosted by the Commission. The chairs are elected by the Competent Authorities on Medical Devices.
Currently, NBOG is chaired by
Dr. Rainer Edelhäuser
ZLG - Zentralstelle der Länder
bei Arzneimitteln und Medizinprodukten
Health Products Regulatory Authority (HPRA)
Kevin O´Malley House
Earlsfort Centre, Earlsfort Terrrace
Work Programme and Working Methods
The work programme of NBOG is defined by the twice yearly Competent Authorities meetings. NBOG works primarily by the production of written guidance and advice.
The usual working method is for one representative of the Group to take the lead in producing a draft of a required guidance paper. This is circulated electronically to the rest of the Group for comments. Appropriate documents may be discussed with the Notified Bodies Group (NB-MED) or the Medical Devices Expert Group (MDEG). The process is repeated until the whole of the Group is able to endorse the document for approval at the Competent Authorities meetings. Endorsed documents will be published on this NBOG website.
NBOG serves also as European “mirror group” for activities of the International Medical Device Regulators Forum (IMDRF) relating to documents being relevant for Notified Bodies.
In general NBOG meets twice a year in Brussels.
Additionally, NBOG provides topic specific training events for Designating Authority assessors and facilitates training opportunities for individual DA assessors. Member States also entrusted NBOG to set up a system of Peer Review of the work of DAs to:
· identify examples of good performance and practice
· confirm consistency of approach in the designation and control of NBs
· detect common problems and shortcomings
· facilitate transfer of skills between Member States
· promote best practice between Member States
· enhance confidence amongst stakeholders.
For further information about the work of NBOG please contact your national NBOG representative.
Reports and News
NBOG reports on its work to the twice yearly meeting of Competent Authorities and to the Medical Devices Experts Group (MDEG).
For transparency and to satisfy the interest of other stakeholders, NBOG produces reports on its work and in particular the current activities of the Designating Authorities to effectively monitor and control their Notified Bodies. These reports supplement the regular progress reports mentioned above.
In addition, NBOG issues News to inform interested parties of the actual discussions within the group.
Central Management Comittee (CMC) on Medical Devices