Framework for Post-Market Surveillance (PMS)

Published in: Medical Devices
Published on: 6 March 2024

The Dutch Health and Youth Care Inspectorate (IGJ) will strengthen oversight of post-market surveillance (PMS) among Dutch manufacturers of medical devices. They will assess how manufacturers conduct PMS and ensure that it is systematically embedded. This means that the IGJ will evaluate manufacturers’ compliance with relevant laws and regulations and will take action if they fail to meet these requirements. The results of these inspections will be shared with the industry in an aggregated manner. This framework focuses on the PMS requirements that manufacturers must comply with under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The goal of the inspection is to assess how manufacturers carry out PMS and the extent to which they meet the requirements of the MDR and IVDR. In doing so, inspection activities are focusing on assessing the PMS plan and PMS reports or the (bi)annual Periodic Safety Update Reports (PSURs). Additionally, the inspection examines the integration of PMS processes with other key processes of the manufacturer’s quality management system (QMS). The inspection expects that this will indicate whether a manufacturer is capable of conducting effective PMS and following up adequately. During the unannounced audits, the IGJ will assess this and take enforcement measures if the PMS requirements of the MDR and IVDR are not met, see the following figure:

During inspection visits, the following aspects will be examined:

  1. Has the manufacturer incorporated the PMS system as a component within its own Quality Management System (QMS)?
  2. Does the manufacturer have the required documentation regarding PMS?
  3. Are PMS or PMCF reports prepared at a frequency appropriate to the nature, intended use, and risk profile of the medical device and the specific requirements of the MDR and IVDR?
  4. Does the manufacturer actively and systematically collect and record relevant data on the quality, performance, and safety of the medical device throughout its lifecycle as part of PMS?
  5. Is the analysis of the collected data structured in a way that enables the manufacturer to draw conclusions regarding the safety and effectiveness of the specific medical device?
  6. Are the results and conclusions of PMS used as input for systematically improving the medical device or implementing corrective and/or preventive actions?
  7. Are the processes that interact with the PMS system executed according to procedure?
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Rebecca Brust

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