Essentials of European Medical Device Regulatory Affairs

Post Market Surveillance Lifecycle Guidance documents note these are being incorporated into the new MDR

MDR #83,84

MDR #87, 88, 89

Reports MDR #85,86

Post Market Surveillance Lifecycle TERMINOLOGY  Post Market Surveillance (PMS) – process of gathering information on a specific device or device family in the post-marketing phase, to monitor its clinical performance and establish if customer needs have been met. The degree of PMS depends on:  Device classification (risk)  Novelty of the device  Lifetime of the device PMS can be both proactive and reactive. Manufacturers must have a PMS plan for each device, aimed at identifying residual risks.  PMCF – intended to answer specific questions relating to clinical safety  and performance (i.e. residual risks)