Join industry's leading experts, including recent notified body leaders and medical experts, for a discussion of solutions and next steps you'll want to consider.

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RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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RQM+_Live_43_Recorded

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:

  • Amie Smirthwaite, BEng, PhD - Senior Vice President, Global Intelligence & Innovation
  • Nancy Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services
  • Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice
  • Andreas Tarnaris, M.D. MD (Res) FRCS (NeuroSur) - Medical Director

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer