Ensure product can be uniquely identified (serialisation)

Article 13(14) of Regulation (EU) 2024/2847 requires that manufacturers shall ensure that the product with digital elements bears a type, batch or serial number or other element allowing the identification of the product.

Where the size or nature of the product with digital elements does not allow for this, the required information shall be placed on the packaging or in a document accompanying the product.

1. Unique product identifier — type designation, model number, batch, or serial
2. Version identifier — for software products, the version number (major.minor.patch or equivalent) must be clearly indicated and accessible to users
3. Placement — on the product itself, or on its packaging or accompanying documents where the product is too small or its nature does not permit marking
4. Consistency — the identifier used on the product must match the identifier in the technical documentation, EU DoC, and any market surveillance correspondence

For software-only products and firmware:

• Use a clear versioning scheme (e.g. semantic versioning)
• Display the current version in the software UI (e.g. "About" screen, settings page)
• Each version placed on the market is treated as a distinct product instance for conformity and support-period purposes

• Physical product markings or screenshots showing version/serial number
• Version history records
• Technical documentation referencing product identifiers
• Correspondence with market surveillance authorities using consistent identifiers