In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two…
Guidance on content and structure of the clinical investigation report summary
According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical…
NB Position Papers on Cybersecurity and “Off-Label” Use
Team-NB recently published various position papers. Two of the latest publications concern Cybersecurity and “Off-Label”…