Post Market Surveillance Plan

Post Market Surveillance Plan (PMS)

The manufactures should NOT consider post market surveillance plan for product family, it should consider to have a PMS plan that is specific to Intended use, construction, risk class and site of action and also the possible outcome.

Continuous evaluation and improvement of the process is at the very heart of this change, the MDR introduces more clear and prescriptive measures based on device risk level.

PMS requirements are very similar for both MDR and IVDR and are mentioned in 7th chapter. Chapter 7 points out to specific Annexes describing more in detail the provisions relating to this topic.

Post Market Surveillance Plan

Contents of Post Market Surveillance Plan (PMS)

Annex III, describes what information shall be included and specifies that this post market surveillance Plan shall be part of the device Technical Documentation. The important pointers are the following..

  • Information concerning serious incidents, including information from Periodic Safety Update Reports (PSUR), and Field Safety Corrective Actions (FSCAs)
  • All records related to non-serious incidents and undesirable side-effects if any
  • Important technical literature and or databases
  • Feedbacks and complaints provided by users and those from supply chain
  • Similar Medical Devices information
  • Proactive and systematic process to collect information concerning to device in question.
  • Appropriate methods to assess the collected data
  • Procedure for continuous reassessment of the benefit-risk analysis and of the Risk Management
  • Appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field
  • Procedure to communicate with Competent Authorities, Notified Bodies or any other regulatory bodies
  • Procedure to identify and initiate Corrective Actions

As for the Post-market Surveillance Report, the Periodic Safety Update Report shall present Results and conclusion of data gathered from the Post-market Surveillance Plan, includes rationale and description of CAPA taken.