When you’re buying or selling first aid kits and medical supplies in the UK, you’ll often see references to ISO 13485 and the CE or UKCA marks. What do these actually mean, and how do they affect product quality and legality? This guide explains the difference between ISO 13485 and CE/UKCA marking, how they apply to first aid products, and what to check before you buy.
For UK workplace contents guidance, see our BS 8599 Standards Guide.
ISO 13485 is the internationally recognised quality management system (QMS) standard for organisations involved in the design, manufacture, and distribution of medical devices and related products (including many first aid components).
An ISO 13485-certified factory demonstrates:
In short: ISO 13485 governs how first aid products are made and controlled.
The CE mark indicates a product meets relevant EU health, safety and performance requirements. The UKCA mark is the UK’s conformity mark for Great Britain. For first aid/medical products, the applicable mark confirms the product complies with the relevant legislation for that market and has appropriate technical documentation and conformity assessment behind it.
In short: CE/UKCA confirms a product is legally compliant for sale. ISO 13485 confirms the manufacturer’s quality system.
| Standard/Mark | Applies To | Demonstrates | Why It Matters for First Aid |
|---|---|---|---|
| ISO 13485 | Manufacturer / facility | Medical-grade quality management & traceability | Gives confidence that dressings, bandages, wipes and kits are produced under controlled, audited processes |
| CE mark | Product (EU market) | Conformity with EU requirements for the device | Indicates the device meets essential safety/performance criteria for EU sale |
| UKCA mark | Product (Great Britain) | Conformity with UK requirements for the device | Indicates the device meets UK rules for GB sale; medical devices follow specific UK routes/timelines |
| BS 8599 | Kit contents (UK guidance) | Recommended item types & quantities | Helps employers choose what to include; separate to CE/UKCA/ISO compliance |
Building or refreshing a kit? Our First Aid Kit Refills Guide and Storage Guide will help.
Together, these ensure your first aid kit is well-made (ISO 13485), legally placed on the market (CE/UKCA), and fit for purpose in the UK (BS 8599 contents guidance). For a refresher on UK kit contents, see What Should Be in a First Aid Kit?
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