January 2021
December 2020
Team-NB members adopted a Position Paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article117 of Medical Device Regulation (EU)2017/745.
Team-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012
Team-NB members adopted a Position paper on Directives expiring certificates – impacts and suggested solutions following a survey among NBs which took place in the automn.
Team-NB-PositionPaper-ExpiringCertificates-20201215
November 2020
Team-NB adopted a Position Paper prepared by the Mirror IVD WG on Team-NB consideration paper on IVDR Date of Application
Team-NB-PositionPaper-Team-NB consideration paper on IVDR Date of Application
Team-NB committee adopted a Position Paper on remote auditing experience following the results of a survey addressed to all Medical Devices Notified Bodies
Team-NB-PositionPaper-RemoteAudits-20201118
37 NBs answered to a survey doing their remote audit experience
NBM-065-20 - Survey Remote Audits - Oct 2020V2.pdf
