Are you presenting the best possible PSUR data for your device?
If you are a manufacturer of a class IIa device or above (with a CE mark under MDR) you will already have had to prepare a periodic safety update report (PSUR) according to article 86 of MDR 2017/745.
Paragraph (c) of that article requires that the PSUR sets out
“the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device”
Thus far, IMed’s team have seen a lot of different approaches to this brand-new requirement and there seems to be considerable confusion with manufacturers around whether the method implemented will be sufficient to demonstrate accurate and realistic information.
The methodology that we feel has generated the best results we have seen, is where manufacturers lay out device-specific examples and calculations, which provide a clear image, not just for post-market surveillance but also for risk management, in the estimations of probability of hazardous situations.
Consider for instance a device used in surgery:
But the device is only marketed in the UK:
And the device is an ophthalmic device, therefore only used in ophthalmic surgery:
So, this already provides a great estimate of the potential maximum size of the population using the device; and also, the characteristics of that population, given that a specialist is required to operate the device. But – we can go even further;
Article 86 also notes the usage frequency, which we can easily estimate with some quick additional research, if we investigate the specific type of surgery that this device is used for. So, let’s say for the purposes of this example that it’s used only in cataract surgery. We can access numerous statistical websites, who record this information. In this case, around 400,000 cataract surgery procedures were carried out within the NHS between 2016-2017, which gives us the frequency of use of the device.
There are of course other questions & criteria, which can keep refining the number of uses. For instance; is your device a single use product? Or if it can be re-used, what is the lifetime of the device?
Every device is unique, so we encourage you to try this exercise for your own products, using search engines, and see what results you get! Or of course, if you’d like our team’s assistance with drilling down into your specific device’s safety references for its PSUR, then please just contact us at email@example.com or on 01295 724286 and we will work together to find the best approach for you and your device.
RA & Clinical Consultant