Clinical Test Report

Fpatterson

Registered
our company has a IVD test and we are preparing for IVDR compliance. the test is essentially an LDT so "packaging" this as an IVD is not straightforward. We are considering the components of the test to include:
- the set of reagents used to conduct the test
- the software used to produce the "score"
- the threshold applied to the score to produce the clinical assessment (prediction)

we as the manufacturer are the only service provider of this test and our ISO 15189 lab uses a specific reporting format to deliver results to a requesting clinician. this report is generated using. a third-party OTS LIMS-style program

My question is should this report be considered a component of the test?
 
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