The Performance Evaluation Plan outlines the resources and procedures for assessing the IVD’s performance.
A separate standard exists for this: EN 13612:2002. It is brief and doesn’t provide extensive detail. You can generally grasp its contents by reviewing the table mapping requirements to document sections below. Additionally, three IMDRF guidance documents are particularly relevant for the Performance Evaluation Report:
- [GHTF/SG5/N6:2012][imdrf-1]
- [GHTF/SG5/N7:2012][imdrf-2]
- [GHTF/SG5/N8:2012][imdrf-3]
Product
- Name: \
- Version: \
- Basic UDI-DI: \
Mapping of Requirements to Document Sections
| EN 13612:2002 Section | Document | Section |
|---|---|---|
| 3.1 Responsibilities and Resources | Performance Evaluation Plan (this one) | 5 |
| 3.2 Documentation | Performance Evaluation Plan (this one) | (all) |
| 3.3 Final Assessment and Review | Performance Evaluation Report | |
| 4.1 Preconditions | Performance Evaluation Report | |
| 4.2 Evaluation Plan | Performance Evaluation Plan (this one) | 6, 7 |
| 4.3 Sites and Resources | Performance Evaluation Plan (this one) | 5 |
| 4.4 Basic Design Information | Performance Evaluation Plan (this one) | 7.3 |
| 4.5 Experimental Design | Performance Evaluation Plan (this one) | 7.4 |
| 4.6 Performance Study Records | Performance Evaluation Plan (this one) | 7.5 |
| 4.7 Observations and Unexpected Outcomes | Performance Evaluation Plan (this one) | 7.6 |
| 4.8 Evaluation Report | Performance Evaluation Report | |
| 5. Modifications During the Performance Evaluation Study | Performance Evaluation Plan (this one) | 8 |
| 6. Re-evaluation | Performance Evaluation Plan (this one) | 8 |
| 7. Protection and Safety of Probands | Performance Evaluation Plan (this one) | 9 |
1. List of Abbreviations
| Abbreviation | Explanation |
|---|---|
| IVD MD | In-vitro diagnostic medical device |
2. Product
- Name: \
- Version: \
- Basic UDI-DI: \
- UMDNS-Code:
- GMDN-Code:
3. Relevant Documents
- SOP Performance Evaluation
- Performance Evaluation Plan
4. Intended Use
Insert the intended use of your device here.
5. Responsibilities and Resources
5.1 Personnel
Assign tasks outlined in EN 13612, and feel free to include additional tasks as needed. One individual may handle multiple responsibilities.
| Task | Personnel |
|---|---|
| Overall coordinator for responsibility | John Doe |
| Assessing the validity of existing test data | John Doe Jr. |
| Defining performance claims for further examination or validation | John Doe Sr. |
| Documenting the evaluation plan and test protocols | John Doe II |
| Composing the final evaluation report | Albert Einstein |
5.2 Resources
List any additional resources necessary for the performance evaluation, such as software, equipment, and physical locations.
6. Performance Claims of IVD MD
Evaluate each performance claim for relevance to your IVD. Specify if you can measure that parameter based on your device’s output and explain the meaning of these parameters in the device’s context.
For instance, if developing an HIV test, analytical sensitivity is relevant, and you might describe it as “the proportion of HIV-positive patients who yield positive results.”
| Performance Claim | Applicable? | Explanation |
|---|---|---|
| Analytical Sensitivity | yes/no | |
| Diagnostic Sensitivity | ||
| Analytical Specificity | ||
| Diagnostic Specificity | ||
| Accuracy | ||
| Repeatability | ||
| Reproducibility |
7. Evaluation Procedure
7.1 List of Laboratories and Other Institutions Taking Part in Study
Include the participating laboratories or “lay persons” if the product is for self-testing.
7.2 Time Table
Outline a timeline for the various stages of the evaluation.
| Date | Activity |
|---|---|
| Planning the Performance Evaluation | |
| Conducting the Performance Evaluation | |
| Drafting the Performance Evaluation Report |
7.3 Briefing of Investigators
Detail how investigators will be informed about the device, especially if they are unfamiliar with it.
7.4 Software Validation
The software is stand-alone and will be validated according to IEC 62366-1:2015, as outlined in the SOP Integrated Software Development.
7.5 Performance Study Records
Specify the storage and management of performance study records, including any analysis and input data (e.g., test sets).
7.6 Observations and Unexpected Outcomes
Explain how to handle unexpected outcomes. This may not be relevant for stand-alone software.
8. Re-Evaluation
Indicate under what conditions the performance evaluation will be conducted again, usually due to changes in the device.
9. Protection and Safety of Probands
Outline the safety measures for the participants. This may not apply to software in most instances.
10. Dates and Signatures
Date and sign the plan. If your document management system supports it, digital signatures may be added, or it can be signed manually.
| Activity | Name | Signature |
|---|---|---|
| Creation | ||
| Review | ||
| Approval |