Outlined below are reasons why PMS is relevant for all stakeholders:
1. Ensuring Patient Safety:
PMS allows the early detection of previously unknown risks that only emerge during the practical use of medical devices. This early identification enables manufacturers to react quickly and take effective measures to minimise risks.
2. Continuously improve products:
Feedback from Post-Market Surveillance serves as a valuable source of data for continuous product improvement. Based on real user experiences manufacturers can adjust their products to optimise their quality, effectiveness and user-friendliness.
3. Meet legal requirements:
All medical device manufacturers must establish a PMS process as part of their quality management system – this is a legal requirement. Only those who comply with this requirement are allowed to bring products to the market.
4. Integration into risk management:
PMS is considered an integral part of risk management. With its help, potential risks and the benefit-risk ratio are continuously monitored and evaluated.
5. Building trust:
The trust of the public, healthcare providers and regulatory authorities in the safety and performance of medical devices after market introduction is crucial. An effective PMS system helps maintain this trust.
Overall, post market surveillance of medical devices is an indispensable part of lifecycle management. It plays a central role in ensuring patient safety and product quality.
