1. Medtech Insight
  2. >>Geography
  3. >>Europe

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

 
• By Amanda Maxwell

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.

Nothing to be scared of! Professional male surgeon wearing protective uniform looking at the camera with surgical instruments in his hands surgical lamp on the background copyspace doctor medical job

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 instructions for use, including indications.

This could include, for example, the documents says: outside specified populations (such as use in pediatrics); for a different stage or severity of disease; for a similar (not identical) clinical...

More from Europe

More from Geography

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.