PMS Output.PNG

What is a PMS System?


The objective of the post-market surveillance system is to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions (CAPA)


What data have to be collect and regulary updated by the manufacturer according

to Article 83?

  • benefit-risk determination and risk management

  • the design and manufacturing information, the instructions for use and the labelling

  • clinical evaluation

  • summary of safety and clinical performance referred to in Article 32 (summary report of safety and clinical performance) 

  • identification of needs for preventive, corrective or field safety corrective action

  • identification of options to improve the usability, performance and safety of the device;

  • when relevant, to contribute to the post-market surveillance of other devices

  • to detect and report trends in accordance with Article 88 (trend reporting)

  • regular update of the technical documentation

What information should the PMS Plan address and include according to Article 84 and Annex III, section 1.1? 

  • information concerning serious incidents, including information from PSURs, and field safety corrective actions

  • records referring to non-serious incidents and data on any undesirable side-effects

  • information from trend reporting

  • relevant specialist or technical literature, databases and/or registers

  • information, including feedbacks and complaints, provided by users, distributors and importers; and

  • publicly available information about similar medical devices.


What are the processes to be covered in the PMS plan?

  • a proactive and systematic process to collect any information, which allows a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market

  • effective and appropriate methods and processes to assess the collected data

  • suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- risk analysis and of the risk management

  • effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field

  • methods and protocols to manage the events subject to the trend report, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period

  • methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users

  • systematic procedures to identify and initiate appropriate measures including corrective actions

  • effective tools to trace and identify devices for which corrective actions might be necessary

  • a PMCF plan, or a justification as to why a PMCF is not applicable