CERGAS SEMINAR "Is the EU regulatory system for medical devices fit for purpose? Matching practice to principles."

The history of medical device regulations demonstrates that systems for approving new technology have been developed as an acute response to problems – the approach has been reactive rather than proactive. That is true both for the EU medical device directives and for the current regulations (EU) 2017/745 and 2017/746.

The principles of European regulatory reform were commendable but they led to much expanded responsibilities for regulatory agencies and notified bodies without adequate expansion of capacity and coordination. Now there are major concerns that devices will disappear from the European market, with severe clinical consequences for patients. Deficiencies of the EU framework include lack of transparency, no system for approving orphan devices, prohibitions on advising manufacturers about requirements for clinical evidence, and no process for introducing innovative products.

There is a pressing need to reconsider why we need regulations, from a clinical perspective, and to design optimal structures from first principles. Regulatory requirements should be proportionate to risk and based on scientific evidence and principles. The EU needs to engage much more with healthcare professionals and engineers to develop guidance. Global regulatory convergence should be a priority. In Europe the CORE-MD project (Coordinating Research and Evidence for Medical Devices) is contributing to the development of regulatory science as an academic sub-discipline.

Speaker: Alan Fraser, Cardiff University

Alan Fraser is Consultant Cardiologist at the University Hospital of Wales, Cardiff, UK; Visiting Professor in Cardiovascular Imaging and Dynamics at the University of Leuven; and Emeritus Professor of Cardiology at the Wales Heart Research Institute, Cardiff University. He qualified in Edinburgh, undertook postgraduate training in Scotland and Wales, and was research fellow at the Thoraxcentre in Rotterdam. He is a Past-President of the European Association of Cardiovascular Imaging, and past Chairman of the Committee on Regulatory Affairs of the European Society of Cardiology. He chairs the Regulatory Affairs Committee of the Biomedical Alliance in Europe and he is Scientific Director of the EU Horizon 2020 CORE-MD project (developing regulatory science for high-risk medical devices). His research interests include cardiac imaging, heart valve disease, heart muscle disease, and the pathophysiology and diagnosis of heart failure.

Link zoom: https://unibocconi-it.zoom.us/j/93226778999?pwd=Q245TlcrRlBaKzJHeDhQZ0k4UmQ4QT09

Meeting ID: 932 2677 8999

Passcode: 843411

For those willing to participate in person, please write to erica.dugnani@sdabocconi.it before Thursday, October 27th.