Medtech Insight publication
Ashley Yeo wrote an article following Team-NB Position Paper publication. The article is available on the Medtech Insight website: https://insights.citeline.com/medtech-insight/policy-and-regulation/eu-notified-bodies-warn-mdrivdr-amendments-will-deliver-lower-levels-of-patient-safety-YGE7WASAXRB7BKZFNO75AUFUWI/
New session : MDR Clinical Training for Manufacturers
TEAM-NB set up a new training for manufacturers dedicated to clinical aspects. What's new: The training has been extended from half a day to a full day. It is planned on May [...]
Position Paper on MDR/IVDR revision: impact on the sector
Team NB fully supports the objective of improving predictability, consistency and transparency in conformity assessment. However, several concerns remain, especially the risk that the proposed reductions in controls could have potential consequences [...]
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 [...]
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