Software really does get a CE mark now
This surprises people. CE marking has historically been associated with physical goods — machinery, toys, electrical equipment — and the idea of affixing it to a downloadable application feels wrong.
Under the CRA it is straightforward: a product with digital elements includes software placed on the market independently of a physical product. It carries the CE marking like any other regulated product, and the marking is the visible claim that the whole conformity process behind it has been done.
Where to put it when there is nothing to stick it on
The rule is that the marking must be affixed visibly, legibly and indelibly to the product. Where the nature of the product does not allow that, it goes on the packaging or in the documents accompanying the product.
For software with no packaging, that means the documentation accompanying the product, the product’s own about screen, or the page it is downloaded from — in each case alongside a means of reaching the declaration of conformity.
- Minimum height 5 mm, with the proportions of the mark preserved when it is scaled.
- Affixed before the product is placed on the market, not afterwards.
- Where a notified body is involved in the production control phase, its four-digit identification number follows the marking.
- No other marking that could mislead a third party about the meaning of the CE marking.
What has to exist before you affix it
The marking is the last step, not the first. Before it goes on, all of the following must be true.
- The product meets the essential requirements in Annex I Part I, and you have the vulnerability handling processes in Annex I Part II.
- A cybersecurity risk assessment is documented (Article 13(2)).
- The Annex VII technical documentation is drawn up.
- The appropriate conformity assessment procedure under Article 32 has been carried out — with a notified body where your product class requires one.
- The EU declaration of conformity is drawn up and signed.
- The Annex II information and instructions accompany the product.