On October 11th general assembly meeting, Team-NB decided to suspend the audits against the Code of Conduct in order to work on the preparation of interpretations on MDR requirements in an objective of harmonisation.
The meeting is held in two parts. The first part is a meeting with representatives of Notified Bodies only and the second part of the meeting will take place with representatives of Notified Bodies, of [...]
you will find below the Team-NB members’ intention to submit their application to be designated against MDR and/or IVDR. The Team-NB notified body members have a double advantage to pass their designation audit : [...]
The political agreement reached is still subject to the approvals (Council's Permanent Representatives Committee and Parliament's ENVI committee). The agreed two draft regulations are expected to achieve a twofold aim : making sure that medical [...]