Performance Evaluation Reports (PER)
Every IVD is required to have a Performance Evaluation Report in accordance with the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) (PER). The three pillars of PERs are clinical performance, analytical performance, and scientific validity.
For IVD makers, gathering data to adequately address each pillar must be a top concern. Notified bodies won't work with manufacturers that can't show that they have procedures in place for IVDR compliance because of the pressure and resource constraints they are under.
Performance Evaluation
Reports (PER)
Performance Evaluation Report
Current Challenges related to PER
Lack of expertise in authoring and updating Performance Evaluation Report
Lack of effective planning to compile and submit the PER’s to Notified bodies meeting regulatory requirements
Scarcity of qualified writers and evaluators with profound knowledge on In Vitro diagnostics
Lack of management practices aimed at timelines meeting regulatory changes
Artixio's Expertise
Regulatory champions with experience in authoring Performance Evaluation Reports for In-Vitro Diagnostics (IVD)
Notified Bodies experience to precisely recommend strategy for Right First Time reports
Clinical and Medical Professionals with decades of experience in evaluating clinical reports
Streamlined Project Management to meet regulatory timelines
Performance Evaluation of In-Vitro Diagnostics
Clinical Evidence
Scientific
Validity
Cinical Performance
Analytical
Performance
Clinical Evidence
Process of Preparing Performance Evaluation Report
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