Support in any kind of Post-Market Surveillance (PMS) activity

The requirements of the new European Regulations concerning medical devices in terms of post-market surveillance are significant. In fact, according to both EU 2017/745 (MDR) and EU 2017/746 (IVDR), for each of the marketed device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. This system should not only be an integral part of the manufacturer’s quality management system, but it should also be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime. It shall also be capable to draw the necessary conclusions and to determine, implement and monitor any preventive and corrective actions.

The following group of documentation is formally required from the manufacturers to meet the PMS-related requirements from the corresponding Regulations:

  • Post-market surveillance (PMS) plan
  • Post-market surveillance (PMS) report
  • Periodic Safety Update Report (PSUR)
  • Post-market Clinical Follow-up (PMCF) plan
  • Post-market Performance Follow-up (PMPF) plan
  • Post-market Clinical Follow-up (PMCF) evaluation report
  • Post-market Performance Follow-up (PMPF) evaluation report

Medidee’s experts have developed unique competencies to assist you in the implementation of a complete PMS system, including processes as well as all of the documentation mentioned above. Most importantly, our Clinical and Regulatory Teams are in continuous and seamless collaboration to support your project from multiple angles, ensuring that your PMS system will not only be in compliance with the latest regulations and guidance documents, but also of the state-of-the-art quality.