IVD Intended Purpose Statements – Defining for Success
RQM+ Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast, too.
The first and arguably most critical step in the IVDR implementation process is determining if you have a compliant intended purpose statement. This has proven to be challenging, even for legacy devices, and has already resulted in notified body findings for manufacturers who are getting a head start over others in the industry.
It's important the intended purpose statement be compliant while also serving the business strategy. Considerations are:
Does the statement meet the definition of an IVD device under IVDR?
Is the statement consistent with the classification of the device under the IVDR?
Is there sufficient clinical evidence and performance data to support the statement?
Will gathering additional data cost more than it's worth to market the product?
Does the statement support what patients need?
Is the statement narrow enough for regulators to accept it given the clinical evidence?
Is the statement flexible enough for payers and providers?
In this show our IVDR experts will discuss strategies for developing intended purpose statements, evidence and a compelling story to tie it all together, so that you can continue to market your IVD under the IVDR.
Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
Ron Sills - Senior Principal Specialist, RQM+
Paul Briest - Operations Manager / Principal Engineer