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 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

Register now to watch the webinar


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About the speaker

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.


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