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