The future of EU MDR: insights and strategies for 2025 (free eBook)

When the European Union Medical Device Regulation (EU MDR) was first published in 2017, it kicked off an enormous amount of conversation, concern, and even frustration in the medical device industry. 

Eight years later, and the conversation is going. While the basic principles of EU MDR are not changing, there has been some evolution in the regulation, along with extensions for some companies, and it’s always a good idea to be up to date on the latest. 

For our new eBook, The Future of EU MDR: Insights and Strategies for 2025, we collaborated with the inimitable Dr. Bassil Akra of the AKRA Team—one of the leading voices on EU MDR compliance. 

If you’re a medical device professional with devices in the EU—or you’re planning to bring a device to market there anytime soon—this eBook is for you.

BONUS RESOURCE: Click here to download "The future of EU MDR: insights and strategies for 2025" for free!

Here’s what you’ll learn about EU MDR in 2025

This eBook provides clarity on the current state of EU MDR, as well as essential tips and strategies for smoothing your path to certification. Here are just a few of the key topics you’ll learn about:

• Understanding Where MDR Stands in 2025: Get a realistic view of the regulation's current status, including recent recommendations for revisions and improvements aimed at making MDR leaner and more reasonable. Learn about critical updates like Article 10a, which introduces new obligations for manufacturers of essential devices.

• Maximizing Your Extension Period (If You Have One): Many manufacturers received extensions for MDR certification, but the clock is ticking. Learn how to leverage this granted time wisely to work towards certification and avoid last-minute hurdles.

• Navigating the Notified Body Landscape: Concerns about a shortage of notified bodies are diminishing as capacity significantly increases. Discover insights into current wait times and learn about your options if your initial notified body can't meet your timeline.

• 5 Tips for a High-Quality Submission: The key to faster certification lies in a strong submission. The eBook breaks down five essential tips to ensure your submission meets notified body expectations.

BONUS RESOURCE: Click here to download "The future of EU MDR: insights and strategies for 2025" for free!

Your path to confident compliance

The Future of EU MDR: Insights and Strategies for 2025 emphasizes that success in this evolving regulatory landscape hinges on a proactive, structured approach to compliance. It’s time to refine your quality system, strengthen your submissions, and ensure your company is not just compliant, but always audit-ready.

Download your free copy of The Future of EU MDR: Insights and Strategies for 2025 today and take control of your compliance journey!