TEAM-NB Position Paper Helps Manufacturers Manage And Benefit From Off-Label Use

Off-label use of otherwise regulated medical devices is not legal but it happens. The EU’s latest position paper on this topic takes a pragmatic approach that aims to support manufacturers, clinicians and patients.

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EU notified body industry association, TEAM-NB, has published a position paper clarifying what manufacturers need to do in the case of off-label use of a device regulated under the Medical Device Regulation.

Off-label use of a medical device is generally accepted to mean when a device is used outside of the approved...