What is the IVDR Performance Evaluation?
Under the IVDR Regulation (EU) 2017/746, all In-Vitro Diagnostic devices (IVDs) must undergo a thorough Performance Evaluation before being placed on the market. This evaluation ensures that the devices meet safety, accuracy, and effectiveness standards for their intended use. Detailed requirements for carrying out a Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) are found in Annex XIII of the IVDR.
Key Areas to Cover in a Performance Evaluation Report (PER)
- Description of the Device/Administrative Particulars
The device description must be clear, including intended use, claims about safety and performance, and any limitations. It’s vital to document hazards, warnings, and clinical benefits thoroughly.
LFH’s top tip: Create a table checklist to ensure you cover all essential points and avoid missing any critical information.
2. Analytical Performance
Analytical performance shows the device’s ability to detect or measure a specific analyte. The PER should summarise verification and validation studies conducted to prove the device’s performance according to Annex I, Section 9.1(a) of the IVDR.
LFH’s top tip: Prepare a table to summarise your Analytical Performance Report (APR) findings and ensure the review process is easier for your notified body.
A summary table will also facilitate a faster review by your notified body (where applicable).
Table 1: An example table that can be used to provide an overview of how the IVDR 9.1(a) requirements have been met (or add justifications where needed).
| Characteristic | Reports providing evidence or justification |
| 9.1 (a) Analytical Performance | |
| Analytical sensitivity | |
| Analytical specificity | |
| Trueness (bias) | |
| Precision (repeatability and reproducibility) | |
| Accuracy (resulting from trueness and precision) | |
| Limits of detection and quantification | |
| Measuring Range | |
| Linearity | |
| Cut-off | |
| Specimen type, collection and handling | |
| Endogenous and exogenous interference | |
| Cross-reactions | |
- Clinical Performance
As outlined in Annex I, Section 9.1(b) of the IVDR, manufacturers need to demonstrate clinical performance. You can rely on clinical performance studies, peer-reviewed scientific literature, and routine diagnostic testing results to prove this.
LFH’s top tip: Create a summary of your CPR and use this in your PER. You may also want to create a summary table that includes the parameters in section 9.1 (b), and clearly document alongside these what reports demonstrate that this requirement has been met or provide a justification where the requirement is not applicable.
A summary table will also facilitate a faster review by your notified body (where applicable).
Table 2: An example table that can be used to provide an overview of how the IVDR 9.1(b) requirements have been met (or add justifications where needed).
| Characteristic | Reports providing evidence or Justification if not applicable |
| 9.1 (b) Clinical Performance | |
| Diagnostic sensitivity | |
| Diagnostic specificity | |
| Positive and negative predictive values | |
| Likelihood ratio | |
| Expected values in normal and affected populations | |
- Scientific Validity Report (SVR)
To demonstrate the scientific validity of an IVD, manufacturers must rely on peer-reviewed literature, expert consensus opinions, or clinical performance study results. This should be clearly documented in both the SVR and the PER. - Risk Management
The PER provides an opportunity to evaluate all clinical evidence and conduct a benefit-risk assessment. Your risk management document should identify the risks associated with the device and justify why the benefits outweigh the risks.
LFH’s top tip: Keep an updated Risk Management File compliant with ISO 14971 to ensure the safety of your device. - Post-Market Surveillance (PMS)
PMS data is critical for validating that your device continues to meet performance expectations after market launch. This data will help support your benefit-risk ratio and demonstrate ongoing safety.
LFH’s top tip: Use post-market surveillance data to show that your device is performing as intended and to ensure long-term market success.
- Conclusions
It’s essential to clearly document the PER conclusions, which should discuss both favourable and unfavourable data. Break down the conclusions into sections for better clarity:
- Conclusion on Analytical Performance
- Conclusion on Clinical Performance
- Conclusion on Scientific Validity
- Conclusion on Risk Management
- Conclusion on Analytical Performance
- This will help ensure that all areas are adequately addressed.
LFH’s top tip: Write a final conclusion to summarise how your device meets safety and performance requirements and highlight its benefits.
Need Help with Your Performance Evaluation Documentation?
Whether you need assistance with preparing your PER in compliance with the IVDR, performing a gap analysis, or reviewing technical documentation, our team of experts can help. Contact us today via phone at +441484662575, email at info@lfhregulatory.co.uk, or visit our Contact Us page to get started.
FAQ’s for IVDR Performance Evaluation
What is an IVDR Performance Evaluation?
It is the process of proving that an in-vitro diagnostic device (IVD) meets EU IVDR requirements for safety, accuracy, and clinical effectiveness before market launch.
Which documents are required under IVDR for performance evaluation?
Manufacturers must prepare a Performance Evaluation Plan (PEP) and a Performance Evaluation Report (PER), as detailed in Annex XIII of the IVDR.
What does analytical performance cover in an IVDR evaluation?
It demonstrates how well the device detects or measures the intended analyte, including sensitivity, specificity, precision, accuracy, and limits of detection.
How is clinical performance demonstrated under the IVDR?
Manufacturers must provide evidence from clinical performance studies, peer-reviewed literature, or diagnostic testing that the device delivers reliable results in its intended population.
What is the role of the Scientific Validity Report (SVR)?
The SVR establishes the link between the analyte and the clinical condition of interest using scientific literature, expert consensus, or study results.
How does risk management fit into performance evaluation?
Manufacturers must carry out a benefit-risk assessment, updating the Risk Management File (in line with ISO 14971) to show that benefits outweigh any risks.
Why is post-market surveillance (PMS) important for IVDs?
PMS data confirms the device continues to meet safety and performance standards after launch and supports updates to the benefit-risk assessment.
What are the key outcomes of a Performance Evaluation Report (PER)?
The PER must conclude on analytical performance, clinical performance, scientific validity, and risk management, showing compliance with IVDR standards.
