EU MDR: Compliance Requirements From a Vigilance Perspective
Companies attempting to comply with Medical Device Regulation (EU) 2017/745 (MDR), introduced in May 2021 for medical device certification in the...
The transition phase to MDR (Regulation (EU) 2017/745) has been underway since mid-2020 and has introduced new requirements for medical devices.
Experience gained with numerous Notified Bodies during this critical time has highlighted common pitfalls and areas where medical device companies face the greatest challenges. However, it has also shown how companies who have successfully navigated the FDA can use this to their advantage in the CE marking process.
In this recorded webinar, Kristi Nakayama, Antonia Claasz and Paige Sutton-Smith from Veranex guide you through some of the most important aspects you should consider for your MDR submission, including:
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Overview of requirements of CE marking per the MDR
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Potential gaps to be bridged
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Advantages of previous FDA clearance/approval
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