Post-Market Surveillance (PMS) and Post-Market Performance Follow up (PMPF)
The IVDR sets out that ‘the clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device.’ So, to fulfil post-market requirements, you’ll need to conduct a Post-market Performance Follow-up (PMPF).
The PMPF is meant to be a continuous collection of clinical data on the performance of your device after it has been placed on the market.
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Post-market information, such as data from the manufacturer’s post-market surveillance system should be reviewed regularly and used to determine the potential impact on the risks, clinical benefit and whether there is a need to update the performance evaluation report of the IVD.
As a manufacturer, you must ensure that all appropriate methods, procedures and product-specific triggers to proactively collect and evaluate safety, performance and scientific data are included as part of your PMPF plan.
Our team can support you with:
- Developing comprehensive PMPF strategies and plans
- Identifying relevant data sources, establishing data collection protocols and implementing systems for timely data analysis and reporting
- Updating PEP or PER as part of the PMPF
- Updating IVD clinical evidence, as appropriate
- Post-market performance studies
- Establishing procedures for signal detection, investigation and risk management, including the implementation of corrective and preventive actions (CAPAs) as necessary
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