What is the webinar about?


This webinar provides an in-depth overview of the Medical Device Regulation (MDR) clinical requirements as they apply to spinal implants. It will cover key regulatory expectations for clinical evaluation, clinical evidence, and post-market clinical follow-up (PMCF), with a focus on demonstrating safety and performance. 
 

Who should attend?

  • Research & Development (R&D) of Medical Device Manufacturers
  • Regulatory Affairs Professional, Regulatory Agency or Government Body (including Notified Body)
  • Clinical Professional (e.g., clinician, other healthcare provider)
  • Research Professional (Academia or Consulting Firm)
  • Other
     

What will participants gain?

You will gain a clear understanding of the MDR clinical requirements applicable to spinal devices, with practical insights relevant to manufacturers. The webinar will cover:

  • The impact of the EU MDR on spinal devices and associated clinical requirements
  • Clinical safety and performance objectives under MDR
  • Acceptable sources of clinical data, including PMCF studies, registries, scientific literature, and PMS activities
  • Common issues identified during submissions and conformity assessments by notified bodies
  • A live Q&A session to address participant questions and real-world challenges

Speakers

 
Marion
Soubelet
Principal Technical Specialist & Scheme Manager, BSI
 
 
Dan
Hoehn
Technical Team Manager, Orthopaedic & Dental, BSI
 
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