How does traceability work when you sell medical products?

Traceability means being able to show where each product came from and where it went. For medical devices, this isn’t a luxury but a requirement, and it must work when you need it. That’s only possible if tracking begins the moment the product arrives.

Being able to look in two directions

Just as with batch registration for cosmetics, you want to be able to trace a batch back to the orders that were shipped from it, and trace a complaint back to the batch. These two directions together make a recall targeted, rather than an action where you have to contact everyone because you’re not sure.

The journey begins with your supplier

The batch information must be included with your purchase. If it’s missing there, no warehouse will be able to create it later. This is the part of the supply chain that you need to manage yourself before your inventory is shipped.

Record upon arrival

Upon arrival, the lot number, shelf life, and location are recorded. From that point on, the system knows which lot is located where, and this information can be linked to the picking process. Without that first step, the rest doesn't work.

Link to the order

During the picking process, the system records which batch an item comes from. This means that every order shipped is linked to the batches it contained. That’s the information you’ll need to look up if there’s an issue.

Be mindful of your speed

In a recall, what matters is how quickly you can act. If the data is already in the system, it’s just a matter of retrieving it. If you have to reconstruct it afterward from packing slips and emails, it will take days, and the damage will be greater.

You remain responsible

When dealing with a regulator or a customer, you are the one who is accountable—not the warehouse. So make sure you know how to retrieve the data and that you’ve practiced doing so at least once before it really matters.

Test Your Own Supply Chain

Pick a random shipped order and try to figure out which batch it came from. If you can do that in a few minutes, your traceability is in good shape. If you can't, then you know where the gap is.

Where the requirements come from

The requirements regarding the traceability of medical products are set forth in the European Medical Device Regulation. What this means for your product line depends on the class into which your products fall. The storage requirements set by a warehouse are aligned with these requirements.