He presented the concerns Notified Bodies have on the implementation of the new regulations. During an extensive round of discussion various obstacles and unclear requirements and possible options to overcome such interesting challenges were discussed.
The topic of the entire day was the implementation of the new MDR and the impact to their members. Hans-Heiner Junker provided a speech on two topics: Impact on Technical Documentation and Impact on [...]
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 : [...]