Medical devices play an important role in the continued improvement of healthcare, yet they can be complex and are increasingly high tech. This technical complexity represents both their strength and their weakness. The strength is self-evident- the potential for improved quality of patient care and cutting-edge treatment, the weakness is more complicated. One dimension of this weakness can be summarised in the question: How can clinicians keep pace with rapid technological change and product turnover, and make informed decisions about whether to use one device rather than another? The introduction of medical device representatives (MDRs) into the clinical environment has been industry’s response to this question. The role of MDRs raises a number of regulatory issues that will be the focus of this presentation. These include : patient consent, the outsourcing of expertise, potential conflicts of interest (commercial versus clinical), harm to professionalism, dependence on MDRs and the risk of stifling innovation through overregulation. In short, does the insertion of device representatives into the clinical relationship represent a help, a hindrance or a liability?’