Real-World Lessons from Companies Navigating the Challenges in Achieving EU-MDR Certification

Are you ready for the EU-MDR? The new regulations took effect and ensuring your device can successfully go to market in the EU requires certification under them. Planning for these adjustments takes concerted effort, close collaboration and intentional organizational adaptations.

Does your team know all the bumps, hurdles and secrets to get you through? Your notified body may be accredited but do they have “qualified” reviewers for your clinical, quality and technical files? Are you prepared for things such as technical documentation delays? What type of course correction do you have in place in case your CE Mark/QMS certification process takes longer than expected? Your stakeholders will want to know.

Join us to gain an understanding of common hurdles and how to overcome them.

Key Takeaways:

• What to know about expected challenges during the transition
• Where to focus and prioritize in the EU-MDR certification process
• Coordinating and planning around your Notified Body
• Balancing the Technical file and QMS audit review
• How to incorporate the new EU-MDR framework into your company’s QMS
• Getting ready for the EUDAMED database