Post-market surveillance: Strategy to prevent costly nightmares
9:50 AM - 10:30 AM
As medical devices are designed, developed, manufactured and distributed on the market, a residual risk with regard to the medical device’s safety and performance remains throughout the product life cycle. Monitoring of products after they have been approved for use can be a nightmare of compliance for manufacturers, but the knowledge gained from customer feedback and complaints is an integral part of improving next-generation products and innovations.
Data collection is a key part of an effective and functional post-market surveillance, and requires almost as much thought as the research itself.
Understanding the increased obligations now placed on manufacturers and other economic operators associated with post-market surveillance (PMS) requirements is essential for manufacturers to comply with the MDR – Regulation (EU) 2017/745. Implementation should commence as soon as possible and regulatory advice should be obtained where manufacturers are unclear about what is expected of them.