EU MDR and its impact on cardiovascular manufacturers

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.

Key topics covered:

• 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

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.

Related Services: Cardiovascular Medical Devices | Medical Device Regulation (MDR) | EU In Vitro Diagnostic Medical Device Regulation (IVDR)