What is a Performance Evaluation Report?
EU 2017/746 – also known as the In Vitro Diagnostic Medical Devices Regulation (IVDR) was adopted on May 25, 2017, and will replace the In Vitro Diagnostic Medical Devices Directive (IVDD). There is a transition period of 5 years making the Regulation fully applicable on May 26, 2022. Compared to the IVDD, there are massive changes confronting manufacturers with numerous challenges.
From the IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP) and clinical evidence file that should be combined as a performance evaluation report (PER)
Requirements of PER
- Intended use or purpose of the device
- Indications for use, limitations, and contra-indications
- The General Safety and Performance Requirements (GSPR) supported by your performance evaluation
- List of recorded evidence for the device
- Performance specifications of the IVD
- A description of the current state of the art
- Benefit-risk ratio parameters
- List of analytical tests performed and what standards are used
- Intended target patient groups
- Analyte or marker to be used
- Foundation for underlying software decision making (if applicable)
Our service offerings
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Tech File Submission and Review
- IVDR Readiness Audits and Mock Audits
- Gap Assessments in the existing PER
