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What is Post-Marketing Surveillance?
According to Article 2 of the regulation IVDR 2017/746, post-marketing surveillance (PMS) is defined as “all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”
Actually, IVD manufacturers must mitigate all possible risks from their products to guarantee the safety of the patients before putting products onto the market. However, some risks, (i.e. that arise at a very low frequency) will only appear over time when the products are used on a daily basis in the final routine lab environment. Therefore, the IVD manufacturers should actively and systematically gather information from a device after the manufacturer has placed it on the market to identify those new risks by conducting a continuous PMS.
This is performed by:
- Checking the analytical and clinical performance of the products in use.
- Identifying product defects and previously undetected safety issues.
- Systematically identifying potential risks with the practical usage of the product.
- Continuously updating the benefit-risk assessment.
- Rapidly initiating necessary measures, such as Corrective Actions and Preventive Actions (CAPA).
Due to these requirements, the PMS programs have to be implemented with a formal Post-Market Surveillance Plan (PMSP). The data gathered through PMS activities should be used to update technical documentation showing consistent, regular updates to PMS.
However, the outputs of a PMS plan differ dependent on risk class:
- For Classes A and B IVD medical devices, manufacturers should prepare a PMS report (PMSR) summarizing findings, data and other attributes generated from the plan.
- For Classes C and D IVD devices, manufacturers must generate a Periodic Safety Update Report (PSUR). This report is similar to the PMSR outputs, but also has set additional requirements such as findings from the Post-Market Performance Follow-Up (PMCF) and sales information of the device.
- The PSUR is to be created at least annually, whereas the PMSR can be created every five 5 years.
How can Cerba Xpert support you with the Post-Marketing Surveillance?
Contact Cerba Xpert for the planning and implementation of all activities of your post-market-surveillance (PMSP; PMSR, PSUR,…).
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