When I am drafting the PER, I’ll start with a device description and it’s very important to lay out what the device is about. What is it doing, what are the manufacturer’s intentions for the device? So the reader can understand the device before it goes into the scientific validity, the analytical performance, and the clinical performance. It makes it easier for the reader or the notified body to understand your report, if you report it this way.
So start your report in a way that’s easily understood by the reader. I will go into the intended use and the purpose of the device. You’ll be surprised if the number of reports that I review, and it’s not clear, or it hasn’t been stated clearly what the intended use is, and this is under the IVDD. Note that the IVDD didn’t specify for intended use, but there are certain practices that certain manufacturers have adopted, and it has gone unnoticed, and they don’t clearly state what the intended use or the intended purpose is from certain literature that I review which is not right.
So always make sure you state clearly what the intended use or the intended purpose is. The targeted population that the device is supposed to be using whether it’s pediatrics or adults. If you specify a particular age, make sure that you state those, if it’s for a particular stage in a clinical condition, then make sure that you do state the stage of that particular clinical condition as well.
If it’s in the early stages or the advanced stages, make sure you do state all of this – who the intended user is? is it for the actual patient? is it for the healthcare professional? Make sure all of these things are stated. The use environment or the location for testing – is it in the laboratory, is it at home, in the hospital by the bedside? Make sure all of these things are stated.
Your risk classification – the new classes under the performance evaluation – class A, B, C & D. Make sure you state clearly what the classification of the device is and the rationale behind the classification. A key thing that the notified bodies under the new regulations want to see, especially when it comes to the classification, is not just saying it’s rule number 4 under the IVDR. They want to see you demonstrating how you came to that risk classification. So they want to see you are analyzing all applicable rules of the IVDR, and why you decided to select the particular one that you’ve ended up with.
Device characteristics – what performance are you claiming for your device? Make sure that is clearly stated in the performance evaluation report. Your performance parameters or specification, whether its diagnostic sensitivity or specificity, make sure you state these things clearly like diagnostic sensitivity is to detect that an analyte is testing a particular condition and specificity is opposite of that. So make sure that all of these things are stated clearly within your performance evaluation report.
Make sure you describe the analyte or the marker that you are analyzing. The technology involved in the device, make sure you elaborate on that. Any limitations of your device and contraindications, things that the device should not be used for. All of these things fall under the device description.
Stability parameters – the claimed shelf life, In-use stability, and shipping stability. Temperature controls and storage, all of these things make sure that you state these clearly. By the time you’ve listed all of these things in the report to a very robust level, it makes it easier for the notified body by the time they get into the actual clinical evidence or the clinical data that they’re about to review. It also gives them a good impression of the manufacturer and they know that they are off to a good start and they’ll be in a good mood, and they’ll be able to review and provide some good feedback.
PER is to analyze your clinical evidence and the clinical evidence is really the three things scientific validity, analytical performance, and clinical performance. You want to demonstrate that the clinical evidence that you are gathering, the data that you are gathering from these three parameters has clinical benefits. So your device is going to improve a patient’s life or to make the work of a healthcare professional easier. To demonstrate that the clinical evidence has clinical benefits, demonstrates compliance to the relevant GSPRs. In addition to this, the device must have an acceptable benefit-risk ratio. So you must also demonstrate that your device when used in the environment as intended by the manufacturer, and if you follow the instructions as per the manufacturer will have an acceptable benefit risk ratio. So the benefits of using the device must outweigh any risks, any harm to the patient and you must be able to demonstrate this in your PER. So when you are considering all of this data, you must consider data from your post market surveillance and post market performance follow up as your PMS plan.