Medical Device Reporting

Definitions #

The US FDA process that requires manufacturers to notify them of deaths, serious injuries, or malfunctions involving their medical devices.

Technical The regulatory mechanism under 21 CFR Part 803 requiring device manufacturers to submit MDR reports within specific timelines for reportable events.

Example The hospital submitted a medical device report after an infusion pump caused a serious patient injury.

Etymology #

From FDA's 21 CFR 803 regulation, replacing the older 'Medical Device Problem Reporting' program in the 1980s.

Collocations #

MDR 3500 form FDA 官方表格，用于提交医疗设备报告
reportable event 需报告的严重不良事件（死亡、受伤或故障）
timely MDR submission 按时提交 MDR，通常 30 天或 5 天规则

Real Business Examples #

The manufacturer filed a Medical Device Reporting to the FDA after discovering a software malfunction that led to a patient fall.
Per 21 CFR 803, a reportable event must be reported within 30 calendar days of becoming aware.

Register & Variants #

Register: formal
BrE/AmE: 美国法规术语，FDA 体系

Synonyms & Antonyms #

Synonyms: adverse event report (for devices)

Common Errors #

将 MDR 与 CE 标志中的 MDR (EU Medical Device Regulation) 混淆 FDA 的 MDR 是 Reporting（报告）；欧盟的 MDR 是 Regulation（法规），两者完全不同
仅当设备导致死亡才报告，忽视严重受伤但非致命事件 21 CFR 803.50 要求报告死亡、严重损伤及可能导致以上情况的故障

Confusable Terms #

EU MDR (Medical Device Regulation 2017/745) vs Medical Device Reporting: 欧盟设备法规，替代旧指令，要求 CE 认证；而 FDA 的 MDR 是上市后报告义务
MAUDE database vs Medical Device Reporting: MAUDE 是 FDA 公开的 MDR 数据库，MDR 是报告本身

Frequently Asked Questions

MDR 上报的时限是多少？?

通常 30 天，但涉及死亡或需补救措施时可能需 5 天上报（见 21 CFR 803.10）

MDR 是否适用于进口商？?

进口商需转发信息给制造商，但制造商承担主要上报义务

Published: 2026-09-22 Category: Regulatory