Supervision of post-market surveillance

A great deal of attention is being paid to post-market surveillance in Europe as well. The European legislation on medical devices (MDR) became applicable on 26 May 2021 and the European Regulation on in vitro diagnostic devices (IVDR) became applicable on 26 May 2022. These rules set out what manufacturers are obliged to do in order to monitor the quality of their device (PMS).

The Inspectorate and other supervisory authorities within the EU monitor and ensure that economic operators and devices comply with the statutory requirements for performance and safety. The Inspectorate checks whether manufacturers are in compliance with European and Dutch laws.

Requirements for manufacturer PMS system:

• Manufacturers of medical devices are responsible for the continuous monitoring of the performance and safety of their device for the duration of its existence. The manufacturer will collect data to ensure that the device’s performance and safety is in compliance with the statutory requirements and for improvement purposes, if this should be necessary. The manufacturer will record that data in a technical dossier.
• The manufacturer is obliged to report the results of the PMS activities. These reports will include a Post-market clinical follow-up (PMCF) report (MDR), a Post-market Performance Follow-up (PMPF) report (IVDR) and a Periodic Summary Update Report (PSUR). Please see Figure 1.
• Manufacturers can independently determine how to implement their post-market surveillance. The rules, however, do set out a number of obligations. How a manufacturer organises and implements its PMS will depend on the properties of the medical device.

Transcript

The PMS system

The PMS system must be suitable of actively and systematically collecting, recording and analysing the performance of any device for the entire lifespan of the product. The necessary conclusions can then be drawn from this data and any preventive and corrective actions can be determined, implemented and monitored if necessary. All of this serves to safeguard the safety and quality of the medical device.

The PMS system should at least consist of the following plans and reports:

• The PMS plan must include a PMCF plan, or a justification as to why a PMCF is not applicable. This will be based on the clinical evaluation.
• The manufacturer will analyse the findings of the PMCF and document the results in a PMCF evaluation report, which will then be included in the report on the clinical evaluation and the technical documentation.
• The PSUR or the PMS report must contain a summary of the results and conclusions of the analyses of the data of the PMS that has been collected in accordance with the PMS plan. This report will be supplemented with an outline of any preventive and corrective actions taken.
• The PSUR must inter alia include the key findings of the PMCF for the entire life cycle of the device.

Manufacturers must use the PMS data: 

• to verify whether the benefit/risk ratio has remained favourable
• to monitor the design and the production process
• for clinical evaluation purposes
• to assess when modifications or corrective actions need to be made
• to assess what it can do to improve the usability, performance and safety of the device
• to contribute to the post-market surveillance of other devices, if possible.