Critical Concepts: The Role of Post Market Activities in Establishing Data Sufficiency

In this webinar, our regulatory experts will review the conformity requirements for legacy devices under the MDR and established devices under the IVDR to help you harness the potential of effective post market activities. 

We discuss how legacy devices, defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data. 

Who is this webinar for? 

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

October 5th, 2022 Watch at a Convenient Time Recorded

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To watch the free webinar recording, Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency, fill out the form below.


Takeaways from this session:

  • Learn examples of types of clinical data that are appropriate to use for legacy devices for both MDR and IVDR requirements
  • Understand the MDCG 2020-6 guidance on clinical data for legacy devices
  • And more!
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