Definitions #
A system used by regulators to group medical devices into risk classes, typically from low risk to high risk, which determines the level of regulatory control required.
Technical A tiered risk-based categorization (e.g., FDA Class I/II/III or EU Class I/IIa/IIb/III) that dictates conformity assessment procedures, premarket requirements, and post-market surveillance obligations.
Example The manufacturer's 510(k) submission was required because the device was classified as Class II under FDA rules.
Etymology #
From medical (Latin: medicus) + device (from Old French devis) + classification (from Latin classis + facere). The regulatory use dates to the US Medical Device Amendments of 1976.
Collocations #
- device class I II III FDA 三类风险级别（Class I 低风险，Class III 高风险）
- risk-based classification 基于风险的分类原则，欧盟 MDR 采用
- classification rule 分类规则（如 EU MDR Annex VIII 中的 22 条规则）
Real Business Examples #
- Under the MDR, the software intended to diagnose a disease is classified as Class IIa depending on the rule.
- A device manufacturer must verify the device classification prior to preparing the CE marking dossier.
Register & Variants #
- Register: formal
- BrE/AmE: 全球通用（FDA 与 EU MDR 均采用）
Synonyms & Antonyms #
- Synonyms: risk classification, device risk class
Common Errors #
- 混淆 FDA 分类与 EU MDR 分类，比如认为 Class I 等于 Class I in EU FDA 与 EU 使用不同分类系统，必须根据销售市场分别确定
- 认为分类一旦确定就永不改变 产品设计变更、适应症变化或法规更新可能改变分类
Confusable Terms #
- Device Class I II III (FDA) vs Medical Device Classification
- FDA 具体类目，与 EU MDR 的 Roman numerals 不同
- IMDRF classification vs Medical Device Classification
- 国际协调框架，不直接替代各国法定分类
Frequently Asked Questions
如何确定我的产品属于哪一类？?
需根据目标市场的法规（如 FDA 21 CFR 862-892 或 EU MDR Annex VIII）逐条对照
分类错误会怎样？?
可能导致上市申请被拒或设备被认定为未获批，面临强制召回
Published: 2026-09-24 Category: Medical Devices