ISO TR 20416 defines essential questions to be answered via PMS data sources. But this is not all! With the guidance on the objectives of the PMS, the structured collection of PMS data and the analysis of the gathered data, a manufacturer of medical devices is given the tools to make informed decisions. Even though this is beyond the scope of ISO TR 20416, the tools and guidance how to come to the point at which decisions on actions can be made, are given.
Actions, based on PMS data and their analysis can be manifold and might include:
- Design change
- Review and potential revision of the risk management file
- Review and potential revision of clinical evaluation file
- CAPA
- Reporting of adverse events
- Submission for extended indications
In lieu of a standardized approach to PMS, ISO TR 20416 will give guidance to the manufacturers of medical devices on the objectives and purpose of PMS, potential data sources and data analysis in order to apply informed decision making on the safe and effective use of medical devices. The ISO TR 20416 is planned to be published by mid of 2020.