EU regulations require manufacturers to produce a PMS plan as part of their technical documentation. The plan must be implemented to produce PMS reports (PMSRs) or Periodic Safety Update Report (PSURs) depending on the class of the device.
PMSRs apply to class I medical devices under the MDR, and to class A and B devices under the new in-vitro diagnostic regulation (IVDR) mandate. PMSRs should present results and conclusions of data gathered from the post-market surveillance plans, alongside the rationale and description of any corrective and preventive actions taken.
PSURs apply to class IIa, IIb and III medical devices under the MDR and class C and D in-vitro devices under the IVDR. PSURs are identical to PMSRs with a few additions – manufacturers must publish the conclusion of the Benefit/Risk determination, main findings of the post-market clinical or performance follow-up, sales volume, and estimated user population characteristics and usage frequency.
A compliant PMS plan should consider information concerning serious incidents, records of non-serious incidents, available data on side-effects, information from trend reports, any feedback or complaints provided by users, distributors, or importers of the medical device, and publicly available information about similar devices. Annex III of the MDR 2017/745 lists the following topics to be covered in the PMS plan:
- A systematic and proactive process for collecting information (user feedback, reports, etc.)
- Appropriate statistical and analytical methods of assessing collected data
- Threshold values for assessing risk-benefit and effective risk management
- Appropriate methods and tools for investigating complaints and other experience collected in the field
- Methods for managing events subject to the trend report
- Protocols for communicating effectively with the competent authorities, notified bodies, economic operators, and users
- Reference for procedures to fulfill the manufacturer’s obligations for PMS system, PMS plan, and PSUR
- Procedures and systems for implementing Corrective Actions when required
- Effective tools to trace and identify devices for which corrective actions may be needed (traceability of potentially defective products in case a recall is needed, for example)
All this requirements and much more are covered by «VigilanX».