The Performance Evaluation Plan lays out the resources and methods for the evaluation of the performance of the IVD.
There’s a separate standard available for that: EN 13612:2002. It’s very short and doesn’t contain a whole lot of information. You can generally understand what it’s about when you look at the mapping of requirements to document sections table below. Additionally, there are three IMDRF guidance documents which are more relevant for the Performance Evaluation Report:
- [GHTF/SG5/N6:2012][imdrf-1]
- [GHTF/SG5/N7:2012][imdrf-2]
- [GHTF/SG5/N8:2012][imdrf-3]
| 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 |
| Abbreviation | Explanation |
|---|---|
| IVD MD | In-vitro diagnostic medical device |
Copy-paste the intended use of your device here.
These five tasks are explicitly specified in EN 13612, so you should assign them to someone. Feel free to add further tasks if you have any. Of course, one person can take care of multiple tasks.
| Task | Personnel |
|---|---|
| Coordinator with overall responsibility | John Doe |
| Assess the validity of test results and data already available | John Doe Jr. |
| Specify performance claims which shall be further examined or confirmed | John Doe Sr. |
| Specify and document the evaluation plan and the test procedures | John Doe II |
| Prepare the evaluation report | Albert Einstein |
Describe other resources which you need for performance evaluation, e.g. software and hardware, physical locations.
For each performance claim, assess whether it’s applicable to your IVD, i.e. can you measure that specific parameter, based on your device output? Then, add an explanation about what those parameters actually mean in the context of your device.
An example could be that you’re manufacturing an HIV test. Then, analytical sensitivity is applicable, and your explanation would be something like “proportion of HIV-positive patients who have positive test results”.
| Performance Claim | Applicable? | Explanation |
|---|---|---|
| Analytical Sensitivity | yes/no | |
| Diagnostic Sensitivity | ||
| Analytical Specificity | ||
| Diagnostic Specificity | ||
| Accuracy | ||
| Repeatability | ||
| Reproducibility |
List the labs which take part in your study. If your product is for self-testing, list the “lay persons” who are your study participants.
Create some sort of timeline when to do what.
| Date | Activity |
|---|---|
| Plan Performance Evaluation | |
| Conduct Performance Evaluation | |
| Write Performance Evaluation Report |
If your investigators (the people who conduct the study) aren’t familiar with your device, describe how you’ll provide them with the necessary information beforehand.
The device is stand-alone software and will be validated in accordance with IEC 62366-1:2015, see SOP Integrated Software Development.
Describe how and where records of your performance study will be saved. Those could be files which contain your analysis data, or even the input data (i.e., test set) which you used for it.
Describe what you’ll do when an unexpected outcome happens. Might not apply to stand-alone software.
Specify under which conditions your performance evaluation will be repeated. That’s mainly the case when you change your device.
Describe how you ensure the safety of your probands. Probably not be applicable to software in most cases.
Date and sign the plan. If your document management system supports it, you can digitally sign by typing e.g. your initials in the “Signature” field. Otherwise, you can still sign it the old-school way (print it and sign the sheet of paper, ugh).
| Activity | Name | Signature |
|---|---|---|
| Creation | ||
| Review | ||
| Approval |
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