TEAM NB Position Paper on MDR Certification Process Consensus Document
Members endorsed the work done to harmonise Conformity Assessment Process with description of pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under [...]
MDR Technical Documentation Training for Manufacturers – Survey Report
This press release presents the results of the April training participant survey. It provides information on manufacturers’ progress toward MDR transition and their intentions regarding the transition of their device portfolios. Information [...]
IVDR Technical Documentation Training for Manufacturers
TEAM-NB set up an IVDR technical documentation training for manufacturers on July 2nd , 2026. IVDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
Legal expert opinion on MDR Article 50
A newly published legal expert opinion finds that proposed Article 50 of the MDR Revision would create serious interferences with the freedom to conduct a business under the Charter of Fundamental Rights [...]
TEAM-NB
25 YEARS
44 MEMBERS