Article 10, 10. lays down the requirement for all Manufacturers to have a Post Market Surveillance (PMS) System. The main elements of which detailed in Article 83 (the PMS system), Article 84 (the PMS Plan), Article 85 (the PMS report – for lower risk devices) and Article 86 (the Periodic Safety Update Report (PSUR) - for higher risk devices).
Article 83 lists the fundamental requirements of the PMS system. At this point it’s also worth reflecting on the purpose. The PMS system is intended to continually re-verify and re-validate the results of the development phase with real world data, in order to continually improve the safety and performance of the device. According to Article 83, the PMS system involves at least eight, possibly nine, different processes. But PMS is not a process like those mentioned, nor is PMS an event, like a meeting or a report. It is the collection of the feedbacks loops which have a longer response time than say the vigilance process or the complaint process.
The feedback information in the PMS system is use to:
- update the benefit-risk determination and to improve the risk management,
- update the design and manufacturing information, the instructions for use and the labelling,
- update the clinical evaluation,
- update the summary of safety and clinical performance (if applicable),
- detect reportable trends,
- update the technical documentation,
- identify necessary preventive, corrective or field safety corrective action,
- identify opportunities to improve the usability, performance and safety of the device,
- if applicable, to contribute to the post-market surveillance of other devices,
Therefore, when designing a PMS system, one must start by considering the types of information those eight or nine processes use as feedback. The feedback information required by each process is different: The risk management process requires information about the frequency and severity of harm which results from using the device, manufacturing requires information about nonconformities, the clinical evaluation requires information on clinical performance and so on. This means, the PMS system produces at least eight or nine types of feedback information. Too add to the complexity, generally speaking, the required feedback information isn’t available in the format that the processes need. It has to be produced from assessing different, more fundamental, data. Data like complaints and incidents. Data which has to first be collected, and then assessed in order to produce the needed feedback information. To do that successfully requires a comprehensive Post Market Surveillance plan, defining the data needed, the processes for data collection, and the methods to assess the data. Article 84 requires just such a plan.
Note: At the time of writing this commentary, no guidance had been published by the European authorities on Post Market Surveillance. As guidance becomes available, this commentary will be update.