黄老师
高级工程师 |
| 回答于：2025-12-29 13:01:41 |
Under the EU Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745), the requirement for
permanent direct marking of UDI
primarily depends on the device's classification and intended use context, rather than strictly distinguishing between "multiple-use" and "single-user, multiple-uses" categories.
In general, UDI permanent direct marking requirements apply to devices where such marking is technically feasible and necessary for traceability throughout the device's lifecycle. For single-user, multiple-use devices (e.g., reusable devices intended for one patient but used multiple times), if they fall into the classification scope that mandates UDI marking (most class I devices with measuring function/sterile, class IIa, IIb, III devices), permanent direct marking is typically required—provided the device’s size and design allow for it.
Key notes:
- The core purpose is traceability (e.g., tracking adverse events, recalls), which is equally critical for single-user multiple-use devices as for multi-user multiple-use devices.
- Exceptions may apply if permanent marking is technically unfeasible (e.g., extremely small devices), but manufacturers must justify this in technical documentation and use alternative UDI marking methods (e.g., on packaging) as per EU MDR Annex VI.
It is recommended to refer to EU MDR Annex VI (UDI Requirements) and relevant MDCG guidance on UDI for detailed compliance criteria. Would you need me to help summarize the key clauses of EU MDR Annex VI related to UDI marking for reusable devices?
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黄老师
高级工程师 |
| 回答于：2025-12-29 13:06:29 |
| 说简单点就是，应标尽标，实在放不下，外包装上也行（要有补充说明）
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