Post Market Surveillance
Post Market Surveillance (PMS) under the CE Medical Device Regulation (MDR) is a critical process that ensures the ongoing safety, performance, and effectiveness of medical devices in the European market. It involves systematically collecting, monitoring, and analyzing real-world data and feedback from the use of medical devices after they have been placed on the market.
PMS serves as a proactive measure to identify and address any potential risks, adverse events, or performance issues that might arise once a device is in widespread use. Manufacturers are required to establish a robust PMS system to continuously gather information from various sources, such as user feedback, clinical studies, complaints, and adverse event reports.
The collected data is then analyzed to assess the device's performance against its intended purpose and safety requirements. If any issues are detected, manufacturers are obligated to take appropriate corrective actions, which might include device modifications, labeling updates, or even product recalls if necessary.
PMS is a dynamic process that contributes to improving patient safety, refining device design, and maintaining the overall quality of medical devices in the market. By consistently monitoring devices and adapting to emerging information, PMS helps manufacturers fulfill their responsibilities and regulatory obligations, ultimately benefiting both healthcare professionals and patients.
In summary, Post Market Surveillance is a vital aspect of the CE MDR regulatory framework that ensures the ongoing monitoring and improvement of medical devices to uphold their safety and performance standards throughout their lifecycle.
We provide technical support to assist in the preparation of the Post Market Surveillance documents for compliance with the CE Medical Devices Regulation (MDR & IVDR).
Contact us today, and let's embark on this journey together.
Experience the confidence that comes with working with a proven leader in medical device registration.