This report is a summary of all the activities that you’ve outlined in your PMS plan. It must be focused on the performance, what it will do, and the quality of your device. You have to define how you’re going to get your complaints and feedback. You must also identify how you’ve analyzed the data and what conclusions you’ve made as well as any trends in both serious and non-serious incidents. What information have you found on similar devices that are already on the market? It must be comparable in performance. All of these things have to be included in the report.
This is applicable for class IIa to class III devices. You’ve got the summary of activities that you’ve stated you will carry out in your PMS plan, and you must detail your conclusions that you’ve made with rationale for the actions that you’ve taken. If you had to take particular corrective or preventive actions, or if you had to mandate a design change because of trends in information, for example – why did you carry out such an action? Obviously, you must make sure that you define the field safety corrective actions, and for these corrective actions that you are taking there’s a fine line between them. If you do carry out a field safety corrective action, you must notify your competent authority and notified bodies, get them involved in the process, and communicate appropriately the rationale for corrective actions that you are taking. For the key content of a PSUR, you are finalizing the activities that you’ve defined in your PMS plan, some of which will feed into your benefit and risk ratios. You have to update your risk management plan or file as well. When you’ve done this, what are your conclusions for your benefit and risk ratio? How is it stacking up? What does it look like? Is it getting better or is it getting worse? And, what actions do you need to take?
Your PSUR should have the outcome of your PMCF, and this is very critical. So here, we’ve got a PSUR that needs input from your PMCF, and you’ve got your PMCF that needs to look at elements of your CER. The frequency of carrying out the PSUR must fall in line with your CER frequency because your CER will feed into your PMCF and then your PMCF falls into your PSUR. Now you see how these reports are integrated and annoyingly, some of these processes will be repeated frequently.
Criteria for Serious Incidents – If you get a serious incident that’s classified as death or unanticipated deterioration in the state of health, then you have a maximum of 10 days to report it. If it’s an effect involving a public health threat, then that’s 2 days, and for all other serious incidents, it’s 15 days. Take note of these timelines as they have changed from the MDD. Make sure that you’ve revised your SOPs accordingly. You’ve trained your staff to report these things accordingly and your sales team should know what the new guidelines are.