In this webinar, we 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.
Learn which types of clinical data are appropriate to use for legacy devices
How to effectively identify, present and analyze clinical data for both MDR and IVDR requirements
Understand the MDCG 2020-6 guidance on clinical data for legacy devices
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for IVDR or MDR submissions.
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