July 11, 2019 EU MDR

Post-Market Surveillance Planning and Challenges under EU MDR

PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes. The need for PMS arises immediately upon commercialization of the device.

In developing a robust Post-Market Surveillance process, manufacturers should consider whether or not the product or technology is new to the manufacturer and/or the marketplace. Where a manufacturer has a long history of development and marketing of similar device types, they are likely to have a clear understanding of the patient population and the reasonably foreseeable risk associated with the device. In the case of new technology, manufacturers often have a limited understanding of the patient population and the complexities of the disease state, which may affect the performance of the device. This limited knowledge may result in under or over representation of risks in the pre-market assessment of the device design and its interaction with the patient/user.

For better compliance, being aware about the PMS planning and challenges is important for any medical device industry.