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MDCG 2021-24: Guidance on Classification of Medical Devices was released in October 2021, clarifying spinal implantable medical device classifications.
Related MDR language published in 2017 left room for interpretation. In the absence of official guidance over the past 4+ years of transitioning to the MDR, manufacturers made the case for IIb classification, which was reinforced in 2018 when Team NB published a position paper stating that many spinal implants are Class IIb since they are wedges. MDCG 2021-24, in conflict with that paper, is setting off alarms across the industry as spinal implant manufacturers come to the realization that they have a lot more Class III devices than they planned for.
What is the impact of class III designation to manufacturers? Will additional data be needed? Will existing clinical evidence be sufficient? Will the increased frequency of CER updates and PMCF reports require more resources?
Join industry's leading experts, including recent notified body leaders and medical experts, for a discussion of these questions along with solutions and next steps you'll want to consider.
The panel will include:
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