MEDICA – CEO roundtable by EUROM/SPECTARIS in the presence of Commissioner Várhelyi
Two representatives from the NB team participated in this high-level meeting. President Alexey Shiryaev was invited to take the floor to present Notified Bodies perspectives.
TEAM NB Position Paper on MDR Application and appropriate surveillance Transfer agreement
Team-NB members adopted during the General Assembly meeting, at the unanimity of the NBs presents, a template Agreement form RELATED TO THE TRANSFER OF MDR FORMAL APPLICATION AND OF APPROPRIATE SURVEILLANCE OF [...]
TEAM NB Position Paper on IVDR Changes to companion diagnostic devices
Team-NB members adopted during the General Assembly meeting, at the unanimity of the IVD NBs presents, a guidance on the interpretation used by notified bodies to identify changes affecting the performance, suitability, [...]
Team-PRRC Rome
Team-NB invited to present NBs views on revision of Regulations.
TEAM-NB
25 YEARS
44 MEMBERS