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January 7, 2026
Approximately 5 minutes
Traceability Requirements for Medical Devices in France under EU MDR/IVDR
Traceability Requirements for Medical Devices in France under EU MDR/IVDR
Purpose of Traceability
Traceability enables competent authorities (such as ANSM in France) and manufacturers to identify the origin and distribution chain of medical devices and IVDs throughout their lifecycle. It is essential for effective market surveillance, vigilance activities, incident investigation, and rapid field safety corrective actions. Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), enhanced traceability requirements apply to all economic operators in France. Traçabilité des dispositifs médicaux - ANSM
Unique Device Identification (UDI) System
The UDI system is the cornerstone of device traceability:
- Each device (or type) receives a Unique Device Identifier consisting of a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI).
- UDI must be affixed to the label and packaging (direct marking on the device for reusable devices where feasible).
- UDI-DI and core data elements are registered in the EUDAMED Device module.
- Implementation deadlines depend on risk class (higher classes first).
EUDAMED Registration and Actor Obligations
- Actors: Manufacturers, authorised representatives, importers, and distributors must register in EUDAMED and obtain a Single Registration Number (SRN).
- Device registration: Core data set including UDI-DI, intended purpose, classification, and certificates must be entered.
- Economic operators: Importers and distributors must verify the presence of UDI on devices and maintain records of the supply chain.
Supply Chain Documentation
Economic operators must keep records enabling traceability:
- Manufacturers: retain technical documentation and production records.
- Importers/distributors: keep records of devices received and supplied, including UDI, batch/lot/serial numbers, and supplier/customer details.
- Retention periods: at least 10 years after the last device is placed on the market (15 years for implantable devices).
Vigilance and Incident Reporting
- Serious incidents and field safety corrective actions must be reported via EUDAMED Vigilance module.
- Manufacturers must investigate incidents and provide traceability information to ANSM upon request.
- Traceability data support rapid identification of affected devices and patients.
Special Cases
- Custom-made devices: Exempt from UDI requirement but must ensure traceability through prescription and manufacturer statement.
- Legacy devices: Under transitional provisions, traceability requirements apply progressively as devices are registered or certificates expire.
- Systems and procedure packs: The assembler must ensure traceability of components.
Practical Advice for Operators in France
- Implement UDI early and integrate into quality management systems.
- Register in EUDAMED promptly to obtain SRN.
- Maintain robust supply chain records to respond to ANSM requests.
- Use ANSM and EU MDCG guidance for detailed implementation.
- Prepare for full mandatory EUDAMED use as modules become operational.
Robust traceability under MDR/IVDR strengthens patient safety and facilitates regulatory action in France. Traçabilité des dispositifs médicaux - ANSM
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