I don't have clinical data for my device. What are my options for fulfilling the sufficient clinical evidence requirements under EU MDR?
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Demonstrating "sufficient clinical evidence" is now a clear and enforced requirement for applications under the EU MDR. Additionally, MDR has more explicit requirements to claim equivalency, making it challenging for manufacturers to leverage clinical data generated by other manufactures for similar devices. If you don't have adequate clinical data, what are your options to achieve MDR compliance, especially if you are no longer able to claim equivalency?
In this RQM+ Live! session, our panel will discuss the following and more:
Best practices and novel approaches to fulfilling sufficient clinical evidence requirements, supported by those that have been accepted by notified bodies in audits
Since it is also a requirement to disclose risks of the device, we’ll discuss ideas for predicting occurrence rates when disclosing risks when no clinical data is available — specifically, for new products that do not require clinical trials
Creative ideas for generating data during the COVID-19 pandemic, especially when faced with expectations of receiving minimal feedback or having low study enrollment
Leveraging CERs to meet the “sufficient clinical evidence” requirements
This panel is loaded with former notified body representatives and seasoned R&Q subject matter experts:
Ibim Tariah, PhD, R&Q VP of EU MDR/IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
Ron Sills, R&Q Sr. Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
Jon Gimbel, PhD, R&Q Exec. Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
Celeste Maksim, PhD, R&Q Principal Specialist, and post-market surveillance subject matter expert