Ready to sell your medical devices in Europe? First, you must comply with Europe’s medical device regulations. But instead of a one-size-fits-all approach, there are many ways to demonstrate your compliance – also known as conformity assessment routes.
The conformity assessment route makes it easy for the Notified Body to verify your compliance to the MDD and Essential Requirements. There are many routes to choose from, and your chosen route has implications for your business that you might not expect. How do you know which route is best for you?
What you will learn in this 4-page white paper:
- How does device classification dictate the conformity assessment route?
- Are some routes more cost effective?
- What is the fastest route to achieve CE Marking?
- What factors should I consider when choosing a conformity assessment route?
- How does my chosen route affect my business?
We answer all of these questions and many more in this whitepaper.
About the Author:
Evangeline Loh, Ph.D. RAC (US, EU)
Evangeline is Vice President of 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.