The IGJ Highlights the Importance of an Effective PMS System

The inspections conducted by the Healthcare and Youth Care Inspectorate (IGJ), based in the Netherlands, focused on evaluating manufacturers’ adherence to Post-Market Surveillance (PMS) requirements as outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The key aspects assessed included the integration of the PMS system into the manufacturer’s quality management system (QMS), the adequacy of PMS documentation, and the frequency and content of PMS reports and Periodic Safety Update Reports (PSURs).

What did the IGJ findings reveal about the manufacturers’ PMS system?

• • All of the inspected manufacturers did not have adequate PMS systems set up within their QMS.
  • PMS Plans were not established and even if there is a PMS report or PSUR created, the summary of the PMS results were not sufficient.
  • PSUR’s are not prepared at a frequency that is required for the nature, intended use, risk profile of the device and according to the MDR/IVDR requirements.
  • During review of the PMS documents, it was found that manufacturers are not actively and systemically collecting and recording relevant data on the quality, performance and safety of a medical device throughout its lifecycle.
  • PMS reports often lacked a summary of results and conclusions from the analyzed PMS data, leading to isolated conclusions that did not always result in improvements to the device or taking corrective and/or preventative actions.

While PMS outcomes in relation to a change for design, instructions for use or labelling were picked up in the processes interacting with the PMS system, however, the adjustments to Clinical Evaluation often occurred via the risk management system. Though it was found that not all manufacturers followed the described procedure for updating a clinical or performance evaluation based on the PMS results.

In summary, while manufacturers documented preventive and corrective actions when needed, there were shortcomings in summarizing PMS data, renewing benefit-risk analyses, and establishing clear indicators for action, which are essential for systematic improvements to medical device safety and performance.

You can read the full report here.

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If you would like to discuss more about the IGJ findings and the importance of having an effective PMS system, contact us so our regulatory team can assist you. 

Learn how MedEnvoy can assist you:

• • PMS Compliance Consulting
  • QMS Compliance Consulting
  • RA Consulting
  • QA Consulting