Team-NB Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment
This paper aims to provide harmonized Notified Bodies expectations concerning the demonstration of safety and performance for reagent devices intended to be used in combination with other devices or equipment/instruments. Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216 [...]
Team-NB Letter on cybersecurity in medical devices
Team-NB members endorsed a letter in which they address their views on the efforts to increase cybersecurity of medical devices in Europe for the benefit of patients and, the proposals made to [...]
New session : MDR Technical Documentation Training for Manufacturers
TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on April 29th, 2026. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining [...]
New Member : Scarlet NB B.V.
Team-NB welcomes a new member from The Netherlands : Scarlet NB B.V.
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