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.
About the Authors:
Evangeline Loh, Ph.D., RAC (US/EU):
Evangeline is Vice President of Global Regulatory Affairs at Emergo. Evangeline's areas of expertise include European CE Marking, clinical evaluation reports, vigilance, and device classification in markets worldwide. She previously worked for Cook Medical and holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio.
Ronald Boumans, MsC:
Ronald Boumans is Senior Regulatory Consultant at Emergo's office in The Hague. He previously served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGJ), and his areas of expertise include European medical device legislation, Competent Authority supervision, and CE Marking requirements.