After years of negotiations, the EU’s long-awaited EU Regulation 2017/745 on Medical Devices has been published, replacing the older Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC).
The new regulation came into effect in May 2017 and dramatically changes the conformity assessment process and post-market requirements for medical devices. With the transition period now well underway, manufacturers of products for the European market – regardless of whether they are high- or low-risk devices – must ensure familiarity and compliance with 2017/745.
The key differences between the new regulation and the directives it replaces
How these changes particularly impact high-risk cardiovascular devices
Changes to device classifications and conformity assessment routes
Details of increased clinical and PMS requirements, particularly for high-risk and implantable devices.
How to ensure a smooth transition to MDR certification
Global Director – Cardiovascular Focus Team, TÜV SÜD Ltd, UK
Giovanni has nearly two decades of experience in the medical devices field. His professional experience includes more than 8 years with the two largest EU Notified Bodies and roles in the R&D departments of Sorin and Fresenius Medical Care.
He holds a degree in mechanical engineering from the Polytechnic University of Turin.