ISO 13485 Traceability For Medical Devices
[ISO 13485 Cl 7.5.9]
To ensure that medical devices and their key components can be traced throughout the entire manufacturing, distribution, and post-market stages. This is vital for identifying, investigating, and controlling any defective or nonconforming products.
Key Requirements and Expectations
1. Traceability Proportionate to Risk: The extent of traceability must be appropriate to the risk associated with the device. For example
Class III implantable devices → full traceability (raw materials, components, operators, production lot, distribution, and even end-user if applicable).
Class I devices → limited traceability may be sufficient.
2. Lot / Batch / Serial Number Identification: Each product or batch should have a unique identification number that links it to manufacturing and quality records. This supports quick recall, complaint investigation, and CAPA actions.
3. Records of Components and Material: Records should clearly indicate which raw materials, components, and subassemblies were used in each finished device and the supplier and lot number of each critical input.
4. Traceability During Production: Incoming materials → In-process records → Final device. and Maintain documented evidence such as Device History Records (DHR).
5. Distribution Traceability: The organization must be able to trace the device to the customer and, for implantable devices, to the specific patient if applicable. Records must include-Customer name and address, Device model/lot/serial number, Shipping and delivery date.
6. Special Focus: Implantable Devices: For implantable devices, there are additional requirements: Maintain records of all components, materials, and work environment conditions. Keep these records for at least the expected lifetime of the device or minimum of 15 years (whichever is longer).
7. Software-Based Traceability: If electronic systems are used for tracking, they must be validated (as per 4.1.6) to ensure data integrity and retrieval reliability.
Traceability Records
- Device Master Record (DMR) – defines how the device is made.
- Device History Record (DHR) – documents what was actually made and shipped.
- Batch Manufacturing Record (BMR) – used for each batch or lot.
- Traceability Matrix – links design inputs, outputs, verification, and validation.
Benefits of Strong Traceability
- Enables rapid recall of defective products.
- Simplifies complaint and nonconformity investigations.
- Demonstrates regulatory compliance.
- Reduces risk to patients and company reputation.
Frequently Asked Questions
What is traceability in the context of ISO 13485?
ISO 13485 Traceability is the ability to identify and track a medical device and its components, materials, and records throughout its entire lifecycle from incoming materials, production, distribution, and in some cases, to the final user or patient. It ensures that any defective or nonconforming product can be quickly located, investigated, and recalled if necessary.
How does traceability differ for different device classes?
The level of traceability required depends on the risk class of the device:
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Class I devices: Basic traceability (e.g., batch or lot number tracking).
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Class II / III devices: More detailed tracking (linking raw materials, production batch, testing data, and distribution records).
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Implantable devices: Full traceability including materials, environmental conditions, operators, and patient identification if applicable.
How is traceability managed for software-based systems?
When an organization uses software to maintain traceability records (e.g., ERP, MES, LIMS), the software must be validated according to Clause 4.1.6 to ensure data accuracy, security, and reliability. This validation proves that the traceability data can be trusted during audits, recalls, or investigations.
What are common traceability issues found during audits?
- Auditors often find nonconformities such as:
- Missing or incorrect lot/serial numbers on labels or records.
- Incomplete linkage between raw material lots and finished products.
- No clear procedure for tracing distribution or customer shipments.
- Unvalidated software systems managing traceability.
- Lack of records for implantable device components and conditions.