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EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices

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View this On-Demand webinar here.*

Are you preparing to upgrade your device technical documentation to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If so, this webinar will provide best practices and meaningful tips for manufacturers with devices sold under CE marks. NAMSA EMEA regulatory expert, Vincent Legay, will explain how the EU MDR requirements supersede current EU MDD 93/42 and 2007/47 requirements as they relate to Biocompatibility throughout the full medical device lifecycle.

Also discussed will be information on the specific areas of the EU MDR that enhance ISO 10993-1:2018, as well as other guidelines that support EU MDR requirements for deeper assessment, reduction and control of Biological Risk as they relate to patient concerns.

Lastly, critical MDR information will be provided based on NAMSA’s many interactions with EU Notified Bodies and agencies pertaining to the newly expanded requirements.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com. NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.