The future of medical device regulation in the European Union
Summary
New EU regulations on medical devices will come into force in 2020. Giulio Stefanini, Robert Byrne and Paul Piscoi discuss how new regulation is needed “to reflect the changes in the field over the last decades” and outline what this will mean for the safety of medical devices. What are the most important issues contained in the regulation and how will sufficient clinical evidence for medical devices be measured? How can physicians become involved in the work of expert panels and how do they contribute to medical device regulation?
