What requirements does a warehouse have for the storage of medical devices?

Medical products do not all fall into a single category. A bandage, a thermometer, and a sterile-packed medical device are subject to different regulations, and those regulations determine what a warehouse must ensure. What applies to all of them is a stable environment, fixed storage locations, and a record-keeping system that allows each batch to be traced.

Start with your own classification

Before you can discuss what’s needed in the warehouse, it must be clear which category your items fall under. That determines the storage, documentation, and labeling requirements. As a manufacturer, importer, or distributor, you’re the one who makes that classification—not your logistics partner.

A stable environment

Many medical supplies have specified storage temperatures or must not be exposed to moisture. A warehouse that takes these factors into account will store these items away from loading doors and exterior walls and keep a record of their locations. Therefore, please specify for each item whether any storage conditions apply.

Separating it from the rest of your product line

Medical supplies are kept separate from other products, in their own designated areas. This prevents mix-ups and facilitates monitoring. If you also sell non-medical products, this separation is part of the store layout.

Packaging integrity is more important

For sterile-packaged items, the packaging is part of the product. A dent or tear renders the item unsellable, even if the contents are intact. This requires more careful handling and an inspection upon receipt that checks for such damage.

The administration is keeping up

The lot, shelf life, and location are recorded upon receipt, and when an order is picked, the items that were removed are logged. This provides you with the tracking information you need in the event of a recall.

What you'll continue to do on your own

You are responsible for ensuring that your products comply with labeling, package insert, and registration requirements. A warehouse stores and ships the products you supply; you—either on your own or together with your supplier—are responsible for verifying that your product complies with the regulations.

Lay out your product selection on the table

Because the requirements vary by product group, there is no one-size-fits-all answer that applies to your product line. If we go over your items during our first meeting, it will immediately become clear what is feasible and what information is needed.

Who oversees it

The Health and Youth Care Inspectorate is the regulatory authority for medical devices. The specific requirements that apply to your products depend on the classification you have determined as a manufacturer, importer, or distributor. Whether Cenfil can process your medical products is directly related to this, so please bring that classification with you to the initial meeting.