Understanding Europe's New Medical Device Regulation - MDR 2017/745

You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What do these changes mean and how will they affect your company?

Europe's new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. In this 28-white paper, Emergo's experts in European regulations discuss what you can expect from the new MDR 2017/745 and how it will impact medical device manufacturers. We provide an in-depth look at the changes contained in the MDR, including:

• What are the key changes of the regulation?
• What is the scope of the regulation?
• What are the key terms defined in this update?
• How will EUDAMED and other databases change?
• Factors to consider when timing your transition to the MDR, and...
• 4 potential transition strategies.

We answer all of these questions and much more in this white paper.