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What type of evidence is considered sufficient to comply with the MDR? While we've spoken about this extensively in the past, we explore more ways to arrive at the answer and address many more questions in this RQM+ Live! show recorded 27 April! We were asked for this topic and we have plenty we're excited to share.

Perhaps in certain situations you're asking yourself, "What kind of clinical evidence do I need for my device?"

Our seasoned panelists shared ways to determine exactly that by sharing recent thought processes and examples. We set the tone upfront with a list of factors that affect the 'definition' of sufficient clinical data, generally speaking: intended purpose, novelty, benefit-risk profiles, number of indications, users, where it's used in the world and supportive non-clinical data... just to name a few.

More specifics on what this session covered:

  • Less burdensome, yet effective ways to comply with clinical requirements, using examples from a variety of device types
  • How do you collect clinical data for standard of care devices?
  • How and when can you use Article 61(10) and what is an indirect benefit? Does it make sense for software devices?
  • Is equivalence really no longer useable for Class III and implantable devices?
  • Why monitoring the SOTA could potentially save your company from wasting resources and is much more than just another regulatory requirement
  • Evidence for Annex XVI products (products with no intended medical purpose)

This was a loaded session that our team was incredibly excited about! We tried to provide as much actionable value as possible.


  • Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
  • Jon Gimbel, Ph.D. – Vice President, Technical
  • Bethany Chung, Ph.D., RAC – Principal
  • Sally Sennitt – Medical Director, Intelligence and Innovation

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