The medical implants market is one of the fastest-growing in healthcare. Yet alongside this rapid growth, the industry is facing increasing calls for regulation and oversight. As the demand for innovative medical devices accelerates, how can regulators ensure the highest level of health protection without hindering research and growth in the sector? This tension emerges from the two forces shaping the medical devices market. On the one hand, there are the companies who are driving innovation, eager to bring needed new advances to patients and clinicians as quickly as possible. On the other hand are the regulators, responsible for governing the parameters of these advances and protecting patients through requirements that may require more time to accumulate evidence prior to approval. So how will the latest legislation fare? The new EU Medical Devices Regulation ((EU) 2017/745) will come into force on 26 May 2020 and is intended to “ensure a high level of safety and health while supporting innovation”. Other regulators such as the FDA are also instituting major changes to their medical device regulations. How will these new regulations better guarantee patients’ safety and strengthen confidence on the uptake and diffusion of medical devices? This plenary will explore how our healthcare systems can navigate these controversies surrounding medical devices, and it will identify implications and opportunities for the HEOR community. As well as asking what more needs to be done in terms of regulation, this plenary will also investigate the efficacy of guidance surrounding the generation of relevant real-world evidence to support better decision-making for medical devices. An outline of the medical devices landscape today and the forces shaping its growth will be followed by a discussion among major stakeholders, who will offer their perspectives on what can be done to improve regulation systems. Finally, we will consider how such systems can evolve to keep up with the rapidly-innovating world of medical devices. Join us for an investigation of one of the most pressing challenges facing contemporary healthcare