Performance Evaluation Reports (PER)

Doctor Using Digital Tablet
European Parliament
Performance Evaluation Report

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.

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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.

Current Challenges related to PER

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  • Lack of expertise in authoring and updating Performance Evaluation Report

  • Scarcity of qualified writers and evaluators with profound knowledge on In Vitro diagnostics

  • Lack of effective planning to compile and submit the PER’s  to Notified bodies meeting regulatory requirements

  • Lack of management practices aimed at timelines meeting regulatory changes

Artixio's Expertise ​

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  • Regulatory champions with experience in authoring Performance Evaluation Reports for In-Vitro Diagnostics (IVD)

  • Clinical and Medical Professionals with decades of experience in evaluating clinical reports

  • Notified Bodies experience to precisely recommend strategy for Right First Time reports

  • Streamlined Project Management to meet regulatory timelines 

Performance Evaluation of In-Vitro Diagnostics

Analytical Performance

Scientific 
Validity

Clinical Performance

Clinical Evidence

Process of Preparing Performance Evaluation Report

Stage 1

Identify clinical evidence from:

•Literature search and/or

•Clinical experience and/or

•Clinical performance studies and

•Analytical performance studies

Generate new or additional analytical/ clinical data

No

Is clinical evidence  sufficient to be able to  declare conformity  with relevant ERs?

Yes

Stage 2

Appraisal of individual data sets:

•Suitability

•Contribution of results to demonstration  of performance and safety

Stage 3

Analysis of relevant data:

•Strength of overall evidence

•Conclusion about performance and safety

Performance Evaluation Report

Artixio is helping IVD manufacturers globally with preparation of Performance Evaluation Report for their products. 

We look forward to hearing from you.