Article 84 requires that the PMS System is based on a plan, although the details of the plan are specified in Annex III, 1.1.
In case the relationship between the plan and the processes listed Article 83 was not already clear, Annex III 1.1 starts with a reminder: “The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83”. A reminder that the purpose of the plan, is to produce the feedback information needed to update those eight or nine processes.
While Annex III contains a minimum list of data items that have to be considered in the plan, the actual data items might vary. Keep in mind the commentary on Article 83 above. The correct data elements for a particular device are those data elements from which the full range of feedback information can be produced. However, the starting point is always the following:
- any serious incidents (including any from PSURs) and field safety corrective actions,
- any non-serious incidents and undesirable side-effects,
- any reportable trends,
- any relevant information from literature, databases and/or registers,
- any feedback, including complaints, from users, distributors and importers,
- any publicly available information about similar medical devices.
In addition to defining the data to be collected, the PMS plan must also address the following items:
- the processes to be used to collect the data,
- the methods to be used to assess the collected data (again, the correct methods are those that produce the feedback information needed by the eight or nine processes listed in Article 83),
- the indicators and thresholds to be used in reassessing the benefit risk,
- the methods and tools to be used to investigate complaints and other market feedback,
- the methods and protocols to be used to identify reportable trends,
- the methods and protocols to be used to communicate with stakeholders,
- reference to the PMS procedures to be followed (again, the PMS procedures are those that produce the feedback information needed by the eight or nine processes listed in Article 83),
- the procedures to be used to identify and initiate corrective actions,
- the tools to be used to trace and identify any devices in case corrective actions are needed,
- the PMCF plan or a justification why PMCF is not applicable. See also the dedicated page on Clinical Evaluation.
The Post Market Surveillance plan is part of the Technical Documentation on Post Market Surveillance for the device (Annex III), together with the Post Market Surveillance Report or Periodic Safety Update Report, whichever one is required.
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.