| eMDR | Electronic Medical Device Reporting | FDA's mandatory electronic submission system for Medical Device Reports. |
| FSCA | Field Safety Corrective Action | Action taken to reduce a risk of serious deterioration in health associated with a device. |
| GUDID | Global Unique Device Identification Database | FDA database holding key device identification information for all UDIs. |
| HHE | Health Hazard Evaluation | Structured assessment of patient/user risk used to support recall classification and field-action decisions. |
| MDRmore than one meaning | Medical Device Reporting (FDA) | FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. |
| MIR | Manufacturer Incident Report | Standardized EU vigilance report submitted to competent authorities via EUDAMED. |
| PMCF | Post-Market Clinical Follow-up | Proactive collection of clinical data on a CE-marked device to confirm safety and performance. |
| PMPFmore than one meaning | Post-Market Performance Follow-up | The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. |
| PMS | Post-Market Surveillance | Activities to monitor device safety and performance after market release. |
| PSUR | Periodic Safety Update Report | Periodic EU MDR/IVDR report summarizing post-market surveillance findings. |
| Section 522 | Section 522 Postmarket Surveillance | FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices. |