Register for the webinar | Session 2: 6pm BST
The EU’s new Medical Devices Regulation is bringing radical changes to conformity assessments for medical devices. Ensure you’re ready for the change.
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. Our webinar on 10 October 2017 (9am BST or 6pm BST) will tackle this by looking at:
- 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
This webinar is perfect for compliance, technical, quality and product managers at cardiovascular device manufacturers in the US, Europe and China.
Join us on 10 October, 9am BST or 6pm BST
EXPERT PROFILE: Giovanni Di Rienzo
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.