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.