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 that needs to be included in the Technical File of the medical device.

The following list has 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 feedback and complaints, provided by users, distributors and importers
• publicly available information about similar Medical Devices

and these are completed in 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 the 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

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