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 the Industry association and from European Commission.
NB-MED Chair and vice-president Hans-Heiner Junker attended the Meeting of the Regulatory Affairs Committee meeting of Medtech Europe.
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 Notified Bodies. The seminar took place at the Pullman Hotel in Brüssel and was concluded with a panel discussion. On [...]
Article in Medtech Insight by Amanda Maxwell : EU Notified Bodies Prepare For En Masse Redesignation
EU Notified Bodies Prepare For En Masse Redesignation-Medtech Insight-20170221
Françoise Schlemmer made a presentation during the Open Session Conference of MedPharmPlast General Assembly which took place in Brussels.
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.
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 peer review against the Code of Conduct which requirements are ahead of the today ones. The working groups reviewing [...]