Under the IVDR Regulation (EU) 2017/746 (IVDR), all IVDs must undergo a Performance Evaluation before being placed on the market. The Performance Evaluation is an important aspect of the IVDR, as it ensures that IVDs are safe, accurate, and effective for their intended use. The requirements on carrying out a performance evaluation plan and report are documented in Annex XIII of the IVDR.
There are at least seven essential areas that In-Vitro Diagnostic Medical Device Performance Evaluation Reports (PER) should cover, and these are but not limited to:
1.Description of the device/administrative particulars
A description of the device, including its intended use, indication for use, the technology that the device is based on, hazards & warnings, clinical benefits, claims made about the safety and performance of the device, and limitations should be clearly documented.
LFH’s top tip: Consider using a table as a checklist to document some of this information and make sure you do not miss any of the required points above.
2. Analytical Performance
Analytical performance demonstrates the ability of your device to correctly detect or measure a particular analyte.
As per the IVDR, manufacturers shall demonstrate the analytical performance of the device in relation to all the parameters/characteristics described in point (a) of Section 9.1 – Performance Characteristics of Annex I, unless any omission can be justified as to why this requirement is not applicable.
In your PER, it is expected to see a summary of the verification and validation studies that have been conducted to demonstrate the applicable parameters (also known as performance characteristics or indicators). Standards, guidelines, state of the art, and common specifications (where applicable) should be complied with, and compliance clearly demonstrated. Note that analytical performance should be documented in an Analytical Performance Report (APR).
LFH’s top tip: Create a summary of your APR and use this in your PER. You may also want to create a summary table that includes the parameters in section 9.1 (a) in one column, and what reports demonstrate that these have been met in another column – It’s important to remember to 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 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 | |
3.Clinical Performance
As per the IVDR, the manufacturer shall demonstrate the clinical performance of the device in relation to all the parameters described in point (b) of Section 9.1 – of Annex I, unless any omission can be justified as to why this requirement is not applicable. This may be demonstrated through one or a combination of the following sources:
- Clinical Performance Studies,
- Scientific Peer-reviewed literature,
- Published experience gained by routine diagnostic testing.
Note that the IVDR explicitly states that if clinical performance studies are not performed, a justification is required for why you have relied on other sources of clinical performance data. In your report, it is expected to see a summary of the verification and validation results to demonstrate that your device is compliant to the applicable parameters, standards, guidelines, state of the art, and common specifications (where applicable). Note that clinical performance should be documented in a Clinical Performance Report (CPR).
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 | |
4.Scientific Validity Report (SVR)
It is a requirement to demonstrate scientific validity based on one or a combination of the following sources:
- Relevant information on the scientific validity of devices measuring the same analyte or marker,
- Scientific peer reviewed literature,
- Consensus expert opinions/positions from relevant professional associations,
- Results from proof-of-concept studies,
- And/or results from clinical performance studies.
The scientific validity shall be documented in the scientific validity report, and in the PER.
5.Risk Management:
The PER is one of the first places where all of your clinical evidence comes together in one document. As part of the PER, taking into account all of the available clinical evidence and the risks associated with the device, a benefit-risk assessment should be conducted. The acceptability of the benefit-risk should be clearly documented, and a discussion of why the benefits outweigh the risks or potential risks of the device should be taken into account with the following in mind:
- The generally acknowledged state of the art in medicine, and similar devices benefits and risks.
- Post-market surveillance data (such as complaints, incidents and trends).
6.Post Market Surveillance (PMS):
PMS data is a fantastic source of data, it may be used to demonstrate that your device is performing as intended. In addition to this information being used to demonstrate safety and performance, it’s also a good source of data to assess when determining your benefit-risk ratio; a low level of complaints, especially compared to similar devices on the market is a great way to highlight that your device is safe.
7.Conclusions:
Clearly documenting your conclusions on the findings of your evaluation is essential, both favorable and unfavorable data should be discussed. The conclusions may seem daunting to write due to the sheer amount of data discussed in your PER, but one way of addressing this is to break down your conclusions into sections, for example:
- Conclusion on Analytical Performance,
- Conclusion on Clinical Performance,
- Conclusion on Scientific Validity,
- Conclusion on the current State of the art, and gaps,
- Conclusion on the Risk Management and Benefit-Risk.
This will allow you to focus on one conclusion at a time, and this helps to prevent key information from being missed. We suggest writing a final conclusion to summarise how the device meets the applicable general safety and performance requirements, other standards, guidelines, common specifications (where applicable), its clinical benefits, and last but not least, how the device is safe and performs as intended when used as intended.
Whether you need help with preparing performance evaluation documentation in compliance with the IVDR, reviewing technical documentation, or performing a gap analysis, our team of consultants can provide medical writing or consultancy support to help get your IVD onto the market. Contact us today, either by phone on +441484662575 or via email at info@lfhregulatory.co.uk. Alternatively, you can simply complete the ‘Contact Us’ section below to see how we can help.
