Code of Conduct – Version 5.3
Team-NB members adopted, at the unanimity of the presents, an updated version od the Code of conduct including a new paragraph requiring notified bodies to have a QMS process to investigate suspected [...]
Team-NB statement on Revising the Medical Device Regulatory Framework
Team-NB adopted a high-level position statement outlining key concerns and proposed solutions for the revision of the EU medical device and IVD regulatory framework. The paper calls for a balanced, risk-based approach [...]
Team-NB position paper for participation in Expert panels
This paper is proposing the notified bodies’ outstanding scientific, technical and regulatory expertise for EMA expert panels. This valuable contribution would enhance regulatory clarity, strengthen expert advice and support safer, more innovative [...]
TEAM NB Position Paper on IVDR Certification Process
(including Pre-application, Application and Post Application phases) – Consensus document. Team-NB members adopted, an updated version of a common paper aimed at describing in detail the pre-application and application and Post application [...]
TEAM-NB
25 YEARS
45 MEMBERS