Medical Devices – Latest Updates

Release of a new position paper by Team NB on 'off-label' data

7 October 2022

On October 5, 2022, the European Association for Medical Devices of Notified Bodies (Team NB) published a new position paper on the topic of data originating from the use of a product beyond the approval of the European Medical Devices Regulation (MDR).

This position paper defines the term “off-label use” and addresses whether data generated from off-label use of a product, i.e. so-called “off-label data”, may be used to expand the intended purpose/indications. The paper also points out that, under certain circumstances, an exception can be made from the conformity assessment procedure for a medical device for an unmet medical need.

Subscribe to our Medical Devices News

Stay up to date on regulatory issues relating to the approval and marketing of medical devices


WordPress Cookie Plugin by Real Cookie Banner