CMC


Update in Post-Market Surveillanc


New requirements of Post Market Surveillance (PMS) for Medical Device Manufacturers have been published after the new regulation of Medical Device(MDR) and In Vitro Diagnostic (IVDR).

Post-market surveillance (PMS) plan

The Regulation provides more specific information about what to document and Annex III, what documentation should be included, and also the plan of Post-market surveillance need to be included in the Technical File of the medical device.

The following list are factors to be considered:

  • information concerning serious incidents, including information from Periodic Safety Update Reports (PSUR), and Field Safety Corrective Actions (FSCAs)
  • 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
  • publicly available information about similar Medical Devices

and these are completed in the Annex III by the following list to be covered:

  • a proactive and systematic process to collect information
  • 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 analyze market-related experience collected in the field
  • methods and protocols to manage the events subject to the trend report
  • methods and protocols to communicate effectively with Competent Authorities (CAs), Notified Bodies, economic operators and users
  • reference to procedures to fulfil the manufacturers obligations for PMS system, PMS Plan and Periodic Safety Update Report (PSUR)
  • 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

    Source <https://lne-america.com/library/news/post-market-surveillance-pms-requirements-under-the-new-european-medical-device-regulations>