The EU’s Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) Regulations were introduced to strengthen public health protection and patient safety. However, a recent…
Commission publishes a Proposal for a Regulation to simplify MDR and IVDR
On 16 December 2025, the European Commission published a proposal for a Regulation to reduce and simplify rules on medical and in vitro diagnostic devices.…
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” use of medical devices under MDR. Team-NB is the European…