Post-Market Surveillance (PMS) and Post-Market Performance Follow-Up (PMPF)
Under the IVDR, manufacturers must adopt a proactive approach to post-market surveillance (PMS) to ensure the ongoing monitoring of product safety and performance under actual conditions of use. PMS measures are intended to monitor known risks and their frequency, as well as to detect new, previously unidentified risks. Manufacturers must establish a systematic and proactive process to gather and analyze data throughout the product’s lifecycle, with this information feeding into both performance evaluation and risk management.
Post-Market Performance Follow-Up (PMPF), as part of PMS, is intended to provide continuous monitoring and assessment of a product’s clinical performance after it has been introduced to the market. PMPF activities may include PMPF studies or user surveys to gather clinical performance data.
The PMS system is an integral part of the quality management system and must be maintained and updated throughout the product lifecycle, requiring time and resources. The need for appropriate PMS/PMPF strategies has existed since the IVDR came into effect, even for existing products that currently benefit from extended transitional periods.
novineon CRO ensures a systematic and structured approach to your proactive PMS and PMPF initiatives. In close collaboration with you, we develop the required PMS and PMPF plans, detailing the measures to be implemented and the data to be collected and evaluated. We conduct the data analysis for you and document the results in the PMS report for products in risk classes A and B, and in the regularly updated Periodic Safety Update Report (PSUR) for products in risk classes C and D.
- Development of appropriate PMS strategies
- Preparation and updating of PMS/PMPF plans and reports
- Support in the planning and implementation of PMPF measures
