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The trinity of traceability
Traceability can have different meanings depending on the situation, but one general definition is:
"Ability to track/trace a specific piece of information by means of recorded data or audit trail"
This leads to the the trinity of traceability: You have to consider which traceability is required in the different phases of the life-cycle of your medical device:
Traceability in Design and Development
Traceability in Production
Unique Device Identification (UDI) and Traceability in the Market
Traceability in Design
Traceability starts from the very beginning of the life-cycle.
In your design phase it is important to start documenting traceability between design input and design output, design and tests, between risks and risk controls, between change requests and design documentation.
Why is this so important?
First of all, you want to make sure that all the efforts you invest into the design of your device lead to a product that you can bring to the market. Traceability helps to increase efficiency within the design phase, specifically when different teams are working on the product. You want to make sure that everyone has a clear overview of the status of the design and you need to be able to do an impact analysis of planned changes.
When you have your traceability well documented and accessible to all people involved, it makes it much easier to ensure that all requirements have been met, that all risks have been reduced and that all specifications have been tested.
It links everything together and gives you (and the authorities) a clear overview of the status of your design.
So, it cannot be a surprise that authorities and standardization organizations have included traceability in design as a must within the technical documentation of your device.
Requirements from the FDA and ISO 13485 mention verification and validation, which need to be linked to specified requirements.
Traceability in Production
Once your product has been designed and tested, it can go to production.
When you consider traceability in production, think of the following:
Traceability between purchasing documents, parts and receipt/inspection records
Traceability between equipment used and final products
Traceability between product status and physical locations
Traceability between staff and processes
Production phases of the product: What happened? When? By whom? Were there any deviations? et cetera
This is important for organizational efficiency and it is a regulatory requirement.
Unique Device Identification (UDI) and Traceability in the market
The aim of introducing a system of UDI is to have traceability of medical devices throughout the whole supply chain. This is done to facilitate vigilance, market surveillance and transparency.
2013 seemed to be the year of UDI.
The FDA released its final rule regarding the implementation of UDI for medical devices.
The International Medical Device Regulators Forum (IMDRF) released in the same year its guidance document.
The EU published their recommendation regarding UDI, which later on became integrated into the new MDR and IVDR.
The UDI comes at the end of the production process. It contains information about the device (device identifier) and information about the production (production identifier).
If you want more information on UDI, check out this whitepaper by Emergo Group.
UDI has been introduced to have a more uniform system of traceability of goods in the market. Even though this requirements existed before the introduction of UDI.
It is legal requirement that you know where your goods are so that when there is a need for a field safety corrective action (FSCA) or a recall, you can act quickly and you can provide the correct information to the authorities and the customers/patients.
At this point, everything might actually come together.
If there is for example an issue with one of your devices in the market, it's important that you know if other devices might be impacted as well.
And how would you know that?
When you do your root cause analysis, it's important that you can trace back what happened during production or even further back to the design. Perhaps some changes were made to the design? Perhaps something went wrong in one of the production lines? Which already produced devices are at risk? Where are they?
Don't forget that when you are in such situation, there are deadlines linked to reporting as well. So this is the moment when you have to be able to rely on your traceability system, in every aspect.
In short, invest in traceability and start from the very early phase of your design. Make sure you have a good system to support you and procedures that guide your organization on how to document traceability in the most efficient way.
Like this, traceability and its documentation become part of the daily routine, which will help you, your team, your company and your customers.