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Are You Prepared For The New EU Medical Device Regulation?

Webinar with Mieke Roelants, Director Regulatory Affairs and Market Access
​​​​​​​​​​​​​​9 November 2017

The new EU Medical Device Regulation (MDR) was officially passed in 2017 and manufacturers now have less than 3 years, until 2020, to be fully compliant with all changes set forth within the new regulation.

View this 30 min. webinar to better understand the changes that clinical affairs teams should prepare for now to be successful under the new regulation.

Discussion points include:
•  Impact on the clinical strategy
•  Portfolio analysis
•  Post-market clinical follow-up 
•  Changes to Notified Bodies
•  Clinical evaluation and CER
•  Transparency of information

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