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EU MDR Cost of Compliance: The Results Are In

By Maria Fontanazza
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Here’s what companies think when it comes to how much it will cost to comply with the new regulation.

EU MDR, CE Mark

EU MDR
Of the respondents who expect their companies to actively reduce the number of products available with the CE Mark as a result of EU MDR, half said the reduction would be 10–20%.
Respondents were most concerned with clinical evidence requirements and the availability of notified bodies.

EU MDR

EU MDR deadline
In an alarming response, 78% of survey participants expect to change notified bodies due to EU MDR, and 76% don’t have faith that notified bodies will be able to complete file reviews to meet the deadline.

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About The Author

Maria Fontanazza, MedTech Intelligence

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