ISO recently sent out a working draft for commenting regarding the development of a technical report concerning post market surveillance (PMS) for medical devices (ISO TR 20416 Medical devices – Post-market surveillance for manufacturers). Standards on quality management (ISO 13485), risk management (ISO 14971) and clinical investigations (ISO 14155) already include requirements for manufacturers related to post-market surveillance but are not well aligned with each other. In addition, various guidance documents on PMS or related subjects (e.g. PMCF – post market clinical follow-up) exist. However, none of them defines a comprehensive process for PMS. The proposed Technical Report aims to provide manufacturers information on how to set up a proactive PMS system that is coherent with related requirements of above mentioned international standards but does not contain legislative requirements. The ultimate goal is to describe a comprehensive data collection process (i.e. collecting, evaluating and analyzing data) in order to define appropriate action to improve the device(s) in question.

The Technical Report is intended for use by manufacturers of medical devices but may also help related industries such as combination product manufacturers to plan and conduct PMS activities. Reporting of incidents and other vigilance activities are outside of the scope of this technical report.

It will be interesting to see where this technical report will finally end up and how well it will be aligned with regulatory requirements such as the recently published MDR / IVDR. There is a lot of focus on PMS in the MDR (chapter VII, section 1, articles 83-86; Annex III) but detailed arrangements and procedural aspects will be defined in implementing acts. We can all hope for a good match!

We will keep you posted…