All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–22 of 22
5-Day Report
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Annual Report (PMA)
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Customer Notification Letter
Communication to users notifying them of a safety issue, corrective action, or important product information.
Electronic Medical Device Reporting(eMDR)
FDA's mandatory electronic submission system for Medical Device Reports.
FDA Recall Classifications I, II, III
FDA's risk-based grading of recalls based on potential for harm.
Field Action vs Recall
Distinction between corrective field actions taken on devices in the field and FDA-defined recall events.
Field Safety Corrective Action(FSCA)
Action taken to reduce a risk of serious deterioration in health associated with a device.
Global Unique Device Identification Database(GUDID)
FDA database holding key device identification information for all UDIs.
Health Hazard Evaluation(HHE)
Structured assessment of patient/user risk used to support recall classification and field-action decisions.
Manufacturer Incident Report(MIR)
Standardized EU vigilance report submitted to competent authorities via EUDAMED.
Medical Device Recall
Removal or correction of a marketed device that violates FDA law.
Medical Device Reporting (FDA)(MDR)
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
Periodic Safety Update Report(PSUR)
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Post-Market Clinical Follow-up(PMCF)
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
Post-Market Performance Follow-up(PMPF)
The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.
Post-Market Surveillance(PMS)
Activities to monitor device safety and performance after market release.
Post-Market Surveillance Plan
Documented plan describing PMS activities, data sources, methods, and review frequency.
PSUR (IVDR Specific)
Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.
Removal vs Correction (21 CFR 806)
Reporting categories for field actions: removal physically retrieves the device; correction modifies it in place.
Section 522 Postmarket Surveillance(Section 522)
FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices.
Trend Reporting (MDR/MIR)
Obligation to report statistically significant increases in expected non-serious incidents.