Diving Headfirst into EU MDR with CiteMed

Ethan Drower of CiteMed joins us for this episode of Let’s Talk Medtech to give tips on how to navigate EU MDR.

Omar Ford

March 28, 2022

1 Min Read
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Image courtesy of CiteMed

There’s a lot of uncertainty surrounding European Union Medical Device Regulation (EU MDR) for many medical device companies. It’s an issue that has changed the fabric of regulatory approvals in Europe and the CE Mark is no longer the go-to pathway for companies looking to get innovations out on the market.

CiteMed, a consulting firm, is working to help navigate companies through EU MDR and the global regulatory landscape. Ethan Drower, the co-founder and Operating partner of CiteMed joins us for this episode of Let’s Talk Medtech to discuss how his company is making an impact.

“There's there are a few big issues with the regulation [EU MDR] currently that manufacturers are facing the first and foremost is that there are a lot of details to be to be named later,” he said. “Companies are expected to come up with full proof post market surveillance plans when in the [EU MDR] it is not exactly clear on what is going to be acceptable and what is not going to be acceptable. So, we have some issues with clarity and that always can cause some pain to executives because if it's a toss-up and you're not really sure until you try it … it's very hard to budget timelines and manage expectations.”

 

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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