Post Market Surveillance (PMS) is primarily concerned with establishing the PMS plan for the device. The rationale for establishing a process to do this is; (a) the PMS plan is potentially complex and may involve several stakeholders, (b) if the manufacturer has more than one device, the process will need be repeated for every device or family of similar devices, (c) it has to be part of the Quality Management System (Article 10, 8. (i)).
The PMS plan has to consider the eight processes, or nine if appropriate, which will need updated information during the post-market (post launch) phase. That is the minimum scope. They are listed in Article 78. If it’s not clear which process they are, read the dedicated commentary on the Post Market Surveillance System.
Each of the processes requiring updated information is an expert process. In any organisation larger than a micro enterprise, those processes probably have dedicated process owners. Here are typical examples (for illustration only); Safety/Risk Management function (owner of the benefit-risk determination), Manufacturing (owner of the design and manufacturing information), Labelling department (the instructions for use and label), the Clinical or Medical function (owner of the performance evaluation), Safety and Clinical (the summary of safety and performance), R&D (the usability evaluation), Vigilance (trend identification), Quality (the CAPA and FSCA process), Regulatory Affairs (the technical documentation).
The experts who own these eight or nine processes should be asked the following question: What information was used in the pre-market (pre-launch) phase to conclude; the device was safe, performed as intended and complied with the regulation, that needs to be maintained, re-verified or revalidated in the post-market phase. It may be helpful to ask the expert process owners to formulate questions which they consider need answering in the post-market phase. Again, the questions provided here are for illustration. Each process owner must develop specific questions that are relevant to their process and to the data and information that was used to make critical decisions in the pre-market phase. Or was used as the basis for safety, performance or conformance claims. Questions such as; what claims do we intend to make for the device for which we have an insufficient degree of confidence? What do we still need to learn about the device? Does the device really function as we intended? Did we identify all the hazards? Did we correctly estimate the risks? Is the device being used in accordance with the instructions?
Having the respective process owners formulate such questions is one possible approach. Whatever approach is ultimately followed should be the one that best fits with the culture of the enterprise. Ultimately what matters is that the process owners specify what information they need in the post-market phase to re-verify and re-validate the decisions taken in the pre-market phase and maintain the device as state of the art.
The authors of the regulation reasoned that to obtain new or updated information, new data will have to be collected and be analysed/assessed. As a result, the process owners do not stop with defining (a) the new or updated post-market information their processes need. They must also define (b) what data needs to be collected, (c) how the data should be collected, (d) what methods they intend to use to analyse/assess the collected data in order to produce the post-market information they want. Finally, in cases where the data collection and/or the analysis/assessment is not a continuous real-time process, (e) the required timing or frequency with which the data collection and analysis/assessment should be performed.
There are a number of additional items that also have to be detailed in the PMS plan, but they are all self explanatory. Details can be found in Annex III, 1.1 or in the PMS planning commentary. Likewise, the reporting requirements are also self explanatory. Their details can be found in Articles 80 and 81 or in the PMS reporting commentary. Including the frequency with which the formal reports have to be produced.
In summary, the PMS planning process has the following steps:
- Establish the scope of processes that will need updated information in the post-market phase in relation to the device/device family,
- Identify the responsible process owners,
- Process owners define which information needs to be updated in the post-market phase (one method is by formulating questions to be answered in post-market),
- Process owners specify; what data needs to be collected, how the data should be collected, what methods will be used to analyse/assess the collected data to produced the required information, and if necessary, the timing with which the data collection and analysis/assessment should be performed.
- Agreement on the content, contributors and frequency of the summary report (PMS or PSUR).
For consistency it is recommended to implement a PMS plan template and a PMS report and/or PSUR template. Having a process description, such as the one outlined above, together with standardized templates, would also satisfy the need to have a documented quality system process.
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.